Intra-Vaginal Devices And Methods For Treating Fecal Incontinence

ABSTRACT

Disclosed herein are devices and methods for intra-vaginal bowel control.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/181,576, filed Feb. 14, 2014, which claims the benefit of U.S.Provisional Application No. 61/764,960, filed Feb. 14, 2013, andentitled “VAGINAL BOWEL CONTROL DEVICES AND METHODS OF USE”. The entirecontents of each application is incorporated herein by reference.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

FIELD

This application relates to the field of intra-vaginal devices for thetreatment of fecal incontinence.

BACKGROUND

Fecal incontinence (FI) is one of the most common health problems inwomen. The prevalence of FI is not well understood, primarily becausethe stigma surrounding the condition and the lack of viable treatmentshave deterred many women from seeking medical care. Recent generalpopulation surveys indicate the prevalence of FI at 9% to 12% and ashigh as 24% in older women. These studies have also shown that, althoughprevalence increases somewhat with age, younger women have surprisinglyhigh prevalence rates. The condition is both physically limiting andemotionally devastating. Those afflicted are often forced to withdrawfrom social and professional activities and often face problems in theirprivate personal relationships.

The cause of FI is multifactorial and not completely understood. Oftentimes, women with FI have a history of damage to the pelvic floorstemming from pregnancy and childbirth. Damage can involve the internaland external anal sphincters, pelvic floor muscles, and associatednerves (e.g., pudendal nerve). Puerperal damage to these structures maynot manifest until later in life, possibly due to age-related changes inrectal sensation, compliance, and volume, in addition to furtherweakening of the sphincters and pelvic floor muscles. Many women with FIhave multiple defects in their continence system, making effectivetreatment particularly difficult.

Existing treatments include conservative management, surgicalprocedures, and permanent implants. These treatments all havelimitations in efficacy and morbidity and most of the women with fecalincontinence go untreated. There is the need for a new therapy that islow-risk and offers a high degree of benefit. Disclosed in thisapplication is a new way of treating fecal incontinence. Described is anon-surgical intravaginal device that can protrude into the rectum andprevent accidental bowel leakage.

SUMMARY OF THE DISCLOSURE

In one aspect, an intravaginal device for the control of stool passageis provided. The device comprises a collapsible stabilizing bodyincluding a plurality of segments interconnected by joints andconfigured to modulate between an open state and a collapsed state bymovement of the segments about the joints; an occluding portionpositioned above the stabilizing body, the occluding body configured toprovide a non-extended state and a extended state, the occluding bodyconfigured to occlude the rectum by pushing against a recto-vaginalseptum of a user in the extended state; and a locking mechanismconfigured to maintain the collapsible stabilizing body in the openstate upon engagement of the locking mechanism and permit thecollapsible stabilizing body to collapse upon disengagement of thelocking mechanism.

In some embodiments, the interconnected segments, in the open state,form a loop with a generally oval shape. In some embodiments, theinterconnected segments, in the collapsed state, form a loop withmultiple generally oval shapes. In some embodiments, in the collapsedstate the segments have a lengthwise mid-point that is approximatelyhalf-way between a distal joint and proximal joint, wherein a width atthis midpoint in the collapsed state is narrower than a width of a spacespanned by the segments both proximal and distal to the midpoint. Insome embodiments, in the collapsed state, the approximate lengthwisemidpoint forms a local minimum in the profile of the device. In someembodiments, the occluding portion is configured to protrude into therectum by pushing against a recto-vaginal septum of a user in theextended state. In some embodiments, in the open state, the device has afirst width, a first length, and a first height; and in the collapsedstate, the device has a second width, a second length, and a secondheight, the second width being 50% less than the first width, the secondlength being greater than the first length, and the second height beingsubstantially the same as the first height. In some embodiments, thestabilizing body is comprised of multiple interconnected segments thatare joined together to form a loop. In some embodiments, the stabilizingbody comprises multiple interconnected segments that are joined byjoints, wherein at least one of the joints comprises an elastomericmaterial. In some embodiments, at least a portion of at least some ofthe plurality of segments have an arcuate shape. In some embodiments theplurality of segments is arranged symmetrically about an axis thatextends between the locking mechanism and the occluding portion. In someembodiments, a portion of the collapsible stabilizing body has anarcuate shape and a portion of the collapsible stabilizing body has alinear shape. In some embodiments, the occluding portion is aninflatable balloon, extending from the joint in a generallyperpendicular direction from a plane of the interconnected segments,wherein the joint is located between the balloon and a soft cushionmaterial. In some embodiments, the occluding portion is positioned abovethe linearly shaped portion of the collapsible stabilizing body. In someembodiments, the occluding portion is attached to the periphery. In someembodiments, the collapsible stabilizing body is configured to providean interconnected frame solely forming a structural perimeter of thedevice. In some embodiments, the interconnected frame is comprised ofmetal segments, joined together and surrounded by a soft cushioningmaterial. In some embodiments, at least 3 of the interconnected jointsare configured to be constrained to one degree of freedom of angularmotion. In some embodiments, the collapsible stabilizing body isconfigured to resist out-of-plane bending. In some embodiments, jointsof the interconnected segments are configured to constrain theinterconnected segments to rotational motion in a plane of the frame. Insome embodiments, the occluding portion is positioned above a jointbetween interconnected segments. The occluding portion can be coupled tothe collapsible stabilizing body by a flexible coupling. The occludingportion can be positioned above a joint located opposite to the lockingmechanism. The occluding portion can comprise a support member that isconnected to the collapsible stabilizing body, wherein the supportmember spans less than 50% of a distance across a longitudinal span ofthe stabilizing body in the open state. In some embodiments, in the openstate, the collapsible stabilizing body has a first width and a firstlength; and in the collapsed state, the collapsible stabilizing body hasa second width and a second length, the second width being less than thefirst width and the second length being greater than the first length.In some embodiments, in the open state, the device has a first width, afirst length, and a first height; and in the collapsed state, the devicebody has a second width, a second length, and a second height, thesecond width being less than the first width, the second length beinggreater than the first length, and the second height being substantiallythe same as the first height. The plurality of segments can comprise atleast six segments. In some embodiments, the plurality of segmentscomprises at least four segments. In some embodiments, the stabilizingbody comprises an outer profile, and wherein the interconnected segmentsdeviate from the outer profile at a proximal portion of the stabilizingbody. In some embodiments, the devices comprises an encapsulatingmaterial disposed around the collapsible stabilizing body, theencapsulating material having a first thickness between theinterconnected segments and an exterior surface of the stabilizing bodyin regions disposed away from the occluding portion and a secondthickness between the interconnected segments and an exterior surface ofthe stabilizing body in regions disposed proximate to the occludingportion, the second thickness being greater than the first thickness. Insome embodiments, the device comprises a tensile element attached to thelocking mechanism, the tensile element configured to permitdisengagement of the locking mechanism via application of force to thetensile element. In some embodiments, the tensile element is operativelyconnected to an inflation lumen that communicates with the occludingportion. The tensile element can comprise a string, tube, cable, wire,or cord. In some embodiments, the plurality of segments includes a firstarcuate segment; a second arcuate segment moveably connected to thefirst arcuate segment; a third segment having an arcuate portion and alinear portion, the third segment being moveably connected to the firstsegment; and a fourth segment having an arcuate portion and a linearportion, the fourth segment being moveably connected to both the thirdsegment and the second segment. In some embodiments, the interconnectedsegments move in-plane with a first amount of force, and in the openstate, the interconnected segments move out-of-plane with a secondamount of force, wherein the first amount of force is less than thesecond amount of force.

In another aspect, a method of controlling stool passage in a user isprovided. The method comprises inserting an intra-vaginal device in theuser's vagina, the device comprising a collapsible stabilizing bodyincluding a plurality of segments interconnected by joints, and anoccluding portion, the collapsible stabilizing body being in acollapsible state during insertion; moving the interconnected segmentsabout the joints to modulate the collapsible stabilizing body to an openstate; locking the collapsible stabilizing body in the open state;extending the occluding portion against a recto-vaginal septum of thevagina to at least partially occlude the user's rectum; and retractingthe occluding portion while the stabilizing body is open to permit stoolto pass through the rectum.

In some embodiments, the method comprises applying force to a tensileelement attached to the locking mechanism, unlocking the collapsiblestabilizing body from the open state. In some embodiments, the tensileelement is part of an inflation tube.

In another aspect, an intravaginal device for the control of stoolpassage of an adult human female user is provided. The device comprisesan expandable occluding body; and an intravaginal stabilizing bodysupporting the occluding body to maintain position and stability of theoccluding body in the user's vagina during repeated expansions of theoccluding body in an extension direction to contact the user'srectovaginal septum to at least partially occlude the rectum, thestabilizing body comprising a locking mechanism, the stabilizing bodyhaving a collapsible configuration and a stable open configuration inwhich the stabilizing body is held open by the locking mechanism.

In some embodiments, the stabilizing body comprises a plurality of armsconnected to form a loop. In some embodiments, the stabilizing bodycomprises 4 arms. In some embodiments, the stabilizing body has agenerally ovular shape. In some embodiments, in the open configuration,the occluding body is disposed at a location of the stabilizing bodyhaving a width less than the maximum width of the stabilizing body. Insome embodiments, a thickness of the stabilizing body in the extensiondirection is less than the length of the occluding body in the extensiondirection. In some embodiments, in the collapsible configuration, theoccluding body is supported so that it is disposed in a space betweenportions of the stabilizing body. In some embodiments, wherein thestabilizing body is configured to collapse along its length as it movesfrom the open configuration the collapsible configuration. In someembodiments, the stabilizing body comprises two arms connected by ahinge, the locking mechanism configured to prevent or permit movement ofthe hinge. In some embodiments, the locking mechanism comprises a latchthat is configured to move into and out of a pocket positioned proximateto the hinge between two arms, wherein the latch being positioned in thepocket prevents the two arms from moving relative to one another. Insome embodiments, the hinge and the latch are configured to rotate abouta same point. In some embodiments, the latch is connected to thestabilizing body by a pin joint and is configured to rotate into thepocket. In some embodiments, the locking mechanism comprises a rotatablejoint positioned between two arms configured to allow the opening orclosing of the stabilizing body upon rotation of the joint. In someembodiments, the locking mechanism comprises at least one resilientmember extending across the stabilizing body, holding the stabilizingbody open when the resilient member is in a resting state. In someembodiments, in the resting state, the resilient member is configured tohold the stabilizing body open to a degree greater than the degreedesired when the device is inserted in the patient's vaginal cavity. Insome embodiments, the locking mechanism comprises a detent on an end ofa first arm configured to catch on a feature of an end of a second arm.In some embodiments, the detent comprises at least one of a springloaded ball or a leaf spring. In some embodiments, the feature comprisesat least one of an edge of the second arm or a feature shaped to matewith the detent. In some embodiments, the device comprises a stablecollapsed configuration and a stable open configuration. In someembodiments, at least two of the plurality of arms have a firstconfiguration in which the at least two arms extend inwardly towards acenter of the stabilizing body and a second configuration in which theat least two arms extend outwardly away from the center of thestabilizing body. In some embodiments, the locking mechanism comprises abistable component extending between a first arm and a second arm of thestabilizing body. In some embodiments, the bistable component comprisesa hinge connecting the first arm and the second arm. In someembodiments, a resilient member extends between a first end of the firstarm and a second end of the second arm, the resilient member configuredto be in a first tensioned state when the stabilizing body is in theopen configuration or the collapsible configuration and a secondtensioned state when moving between the open and collapsibleconfigurations, wherein the second tensioned state is higher than thefirst tensioned state. In some embodiments, the device is configured tocollapse into two sections in the collapsed configuration. In someembodiments, the device is configured to collapse into more than twosections in the collapsed configuration. In some embodiments, thelocking mechanism comprises an opening on a first end of a first armconfigured to catch an extension on a second end of a second arm. Insome embodiments, the stabilizing body is configured to collapse byfolding together. In some embodiments, the stabilizing body comprisestwo hinges configured to allow the stabilizing body to fold. In someembodiments, the stabilizing body comprises two additional hingesconfigured to allow the folded stabilizing body to straighten. In someembodiments, the two additional hinges are joints, rotatable only uponfolding of the stabilizing body. In some embodiments, the stabilizingbody comprises a shape memory alloy comprising a transition temperatureother than body temperature. In some embodiments, the shape memory alloyis configured to change shape upon application of temperature orcurrent. In some embodiments, the locking mechanism comprises at leasttwo internal structures with flexible portions, movable relative to oneanother, configured to facilitate device collapse upon alignment of theflexible portions. In some embodiments, the stabilizing body comprisesmultiple frame segments with a tensile member passed through the framesegments. In some embodiments, the locking mechanism comprises a hingewith a sheath movable to cover or expose the hinge, wherein exposure ofthe hinge allows movement of the hinge. In some embodiments, the sheathis configured to prevent motion of the hinge when the sheath covers thehinge. In some embodiments, the device comprises a triggering mechanismconfigured to transition the stabilizing body to the collapsible state.In some embodiments, the triggering mechanism is located proximate to aninflation lumen connected to the occluding body. In some embodiments,the triggering mechanism is coupled to the inflation lumen. In someembodiments, the device comprises an elastomeric portion distal to thetriggering mechanism.

In another aspect, a method of selectively occluding a rectum to inhibitstool passage in a female user is provided. The method comprisesinserting an intravaginal device into the user's vagina, the devicecomprising a stabilizing body and an occluding portion, the stabilizingbody being collapsible during insertion; moving the stabilizing body toan open configuration; engaging vaginal anatomy with the stabilizingbody in the open configuration to stably support the occluding portion;locking the stabilizing body in the open configuration; extending theoccluding portion against a recto-vaginal septum of the vagina bodyduring the engaging step to at least partially occlude the user'srectum; and retracting the occluding portion during while thestabilizing body is in the open configuration to permit stool to passthrough the rectum.

In some embodiments, the method comprises pulling on a distal portion ofthe intravaginal device, thereby causing the stabilizing body tocollapse from the open configuration to the collapsed configuration. Insome embodiments, the method comprises removing the device from theuser's vagina. In some embodiments, pulling on a distal portion of theintravaginal device comprises pulling on a tensile element attached to adistal portion of the device. In some embodiments, the tensile elementcomprises a string, cord, or reinforced tube. In some embodiments, theextending step comprises inflating the occluding portion to a pressureof 40-150 mm Hg. In some embodiments, the engaging step comprisesengaging internal vaginal anatomy to stably support the occluding bodyproximal to the vagina's perineal body while maintaining slack in thevagina wall. In some embodiments, the engaging step comprises distendinglateral walls of the vagina proximate to the occluding portion less thanin areas not proximate to the occluding body.

In another aspect, an intravaginal device is provided. The devicecomprises an occluding portion; and a resilient, deformable,intravaginal stabilizing body supporting the occluding portion, theintravaginal stabilizing body comprising a collapsed configuration inwhich a first portion and a second portion of the stabilizing body arefolded together and an open configuration, wherein the stabilizing bodyis biased towards the open configuration, wherein the first portioncomprises a first material, the second portion comprises a secondmaterial, the first and second materials selected to allow the first andsecond portions to resist separation upon release of the stabilizingbody from the collapsed configuration, thereby dampening opening of thestabilizing body.

In some embodiments, the first portion comprises the first material, thefirst portion is coated with the first material, or the first portion istreated with the first material. In some embodiments, the second portioncomprises the second material, the second portion is coated with thesecond material, or the second portion is treated with the secondmaterial. In some embodiments, the first material and the secondmaterial comprise silicone.

In another aspect, an intravaginal device is provided. The devicecomprises an occluding portion; and a resilient, deformable,intravaginal stabilizing body supporting the occluding portion, theintravaginal stabilizing body comprising a collapsed configuration inwhich a first portion and a second portion of the stabilizing body arefolded together and an open configuration, wherein the stabilizing bodyis biased towards the open configuration, wherein the first portioncomprises a first characteristic, the second portion comprises a secondcharacteristic, the first and second characteristics selected to allowthe first and second portions to resist separation upon release of thestabilizing body from the collapsed configuration. In some embodiments,at least one of the first characteristic and the second characteristiccomprises an adherence feature. In some embodiments, the adherencefeature comprises at least one of a hook and loop feature and amicro-suction feature.

In another aspect, an intravaginal device for the control of stoolpassage of an adult human female user is provided. The device comprisesan occluding portion; and an intravaginal stabilizing body supportingthe occluding portion, the stabilizing body comprising a collapsedconfiguration and an open configuration, the stabilizing body comprisingat least a first and a second arm connected at a joint, wherein thejoint comprises a dampening mechanism.

In some embodiments, the dampening mechanism comprises a viscous fluidsurrounding the joint between the first arm and the second arm. In someembodiments, the dampening mechanism comprises a hydraulic dampeningmechanism.

In another aspect, a method of inserting an intravaginal device in auser is provided. The method comprises inserting, in a collapsedconfiguration, an intravaginal device into the user's vagina, the devicehaving a bias towards an open configuration; releasing the device fromthe collapsed configuration; and dampening movement of the device fromthe collapsed configuration to the open configuration.

In some embodiments, the method comprises adhering a first part of thedevice to a second part of the device, allowing the device bias toovercome the adhering.

In another aspect, an intravaginal device for the control of stoolpassage of an adult human female user is provided. The device comprisesan expandable, occluding portion; and an intravaginal stabilizing bodysupporting the occluding portion having tissue engagement surfaces sizedand shaped to engage with internal vaginal anatomy to maintain positionand stability of the occluding body in the user's vagina during repeatedexpansions of the occluding portion in an extension direction to contactthe user's rectovaginal septum to at least partially occlude the rectum,the stabilizing body comprising a collapsed and an open configuration,the stabilizing body comprising a retaining feature configured to holdthe stabilizing body in the collapsed configuration.

In some embodiments, the retaining feature comprises a latch configuredto hold two portions of the stabilizing body together. In someembodiments, the latch is configured to release when the two portionsare squeezed together. In some embodiments, two portions of thestabilizing body comprise press fit features configured to mate witheach other. In some embodiments, the stabilizing body comprises atensile member configured to draw at least two portions of thestabilizing body together upon application of tension to the tensilemember. In some embodiments, the tensile member comprises a wire, cord,or string. In some embodiments, the tensile member comprises a holdingfeature configured to maintain tension on the tensile member.

In another aspect, a method of selectively occluding a rectum to inhibitstool passage in a female user is provided. The method comprisesinserting an intravaginal device into the user's vagina, the devicecomprising a stabilizing body and an occluding portion, inserting thedevice comprising maintaining the stabilizing body in a collapsedconfiguration by engaging a retaining feature on the stabilizing body;engaging vaginal anatomy to stably support the occluding portionproximal to the vagina's perineal body; releasing the device from thecollapsed configuration; extending the occluding portion against arecto-vaginal septum of the vagina proximal to the vagina's perinealbody during the engaging step to at least partially occlude the user'srectum; and retracting the occluding portion during the engaging step topermit stool to pass through the rectum.

In some embodiments, the maintaining step comprises engaging a latch,thereby holding two portions of the stabilizing body together. In someembodiments, the releasing step comprises squeezing the two portionstogether. In some embodiments, the maintaining step comprises mating afirst press fit feature on a first portion of the stabilizing body witha second press fit feature on a second portion of the stabilizing body.In some embodiments, the maintaining step comprises applying tension toa tensile member, thereby drawing two portions of the stabilizing bodytogether.

In another aspect, an applicator for inserting an intra-vaginal devicein a user's vagina is provided. The applicator comprises a retainingfeature configured to hold the intra-vaginal device in a foldedconfiguration, the intra-vaginal device comprising an expandableoccluding portion and a stabilizing body configured to support theoccluding portion, the folded configuration having a round shape; and atrigger feature configured to release the intra-vaginal device toposition the occluding portion such that the occluding portion canengage the recto-vaginal septum and can expand to occlude the rectum.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIGS. 1A-E illustrate an embodiment of a collapsible intra-vaginaldevice.

FIGS. 2A-H illustrate an embodiment of a device frame and a lockingmechanism.

FIGS. 3A-D illustrate an embodiment of a device frame.

FIG. 4 illustrates an embodiment of a collapsible intra-vaginal device.

FIGS. 5A-B illustrate an embodiment of a collapsible intra-vaginaldevice.

FIGS. 6A-B illustrate an embodiment of a collapsible intra-vaginaldevice.

FIGS. 7A-B illustrate an embodiment of a collapsible intra-vaginaldevice.

FIGS. 8A-B illustrate an embodiment of a collapsible intra-vaginaldevice.

FIGS. 9A-B illustrate an embodiment of a collapsible intra-vaginaldevice.

FIGS. 10A-B illustrate an embodiment of a collapsible intra-vaginaldevice.

FIGS. 11A-B illustrate an embodiment of a collapsible intra-vaginaldevice.

FIGS. 12A-B illustrate an embodiment of a collapsible intra-vaginaldevice.

FIGS. 13A-B illustrate an embodiment of a collapsible intra-vaginaldevice.

FIG. 14 illustrates an embodiment of a segment of a device frame.

FIGS. 15A-D illustrate an embodiment of a collapsible intra-vaginaldevice.

FIGS. 16A-C illustrate an embodiment of a collapsible intra-vaginaldevice.

FIGS. 17A-C illustrate an embodiment of a collapsible intra-vaginaldevice and a locking mechanism.

FIGS. 18A-B illustrate an embodiment of a locking mechanism for a deviceframe.

FIGS. 19A-B illustrate an embodiment of a collapsible device frame.

FIGS. 20A-C illustrate an embodiment of a collapsible device frame.

FIGS. 21A-B illustrate an embodiment of a collapsible device frame.

FIGS. 22A-B illustrate an embodiment of a locking mechanism for a deviceframe.

FIGS. 23A-C illustrate an embodiment of a locking mechanism for a deviceframe.

FIGS. 24A-C illustrate an embodiment of a collapsible device frame.

FIGS. 25A-B illustrate an embodiment of a locking mechanism for a deviceframe.

FIGS. 26A-B illustrate an embodiment of a collapsible device frame.

FIGS. 27A-E illustrate an embodiment of a collapsible device frame.

FIGS. 28A-C illustrate an embodiment of a collapsible device frame.

FIGS. 29A-C illustrate an embodiment of a collapsible device frame.

FIGS. 30A-B illustrate an embodiment of a collapsible intra-vaginaldevice.

FIGS. 31A-C illustrate an embodiment of a collapsible device frame.

FIGS. 32A-B illustrate an embodiment of a collapsible device frame.

FIGS. 33A-B illustrate an embodiment of a collapsible device frame.

FIGS. 34A-B illustrate an embodiment of a locking mechanism for a deviceframe.

FIGS. 35A-D illustrate an embodiment of a collapsible device frame.

FIGS. 36A-B illustrate an embodiment of a collapsible intra-vaginaldevice.

FIGS. 37A-D illustrate expansion of an embodiment of a collapsibledevice frame.

FIGS. 38A-F illustrate an embodiment of a device configured to be drivenopen by expandable member.

FIGS. 39A-C illustrate an embodiment of an intra-vaginal devicecomprising a latch.

FIGS. 40A-B illustrate an embodiment of an intra-vaginal devicecomprising mating features.

FIGS. 41A-C illustrate an embodiment of an intra-vaginal devicecomprising a tensile member.

FIG. 42 illustrates an embodiment of a device frame comprising akeystone feature.

FIGS. 43A-C illustrate an embodiment of an intra-vaginal devicecomprising foam.

FIGS. 44A-B illustrate an embodiment of an intra-vaginal devicecomprising a movable expandable body.

FIG. 45 illustrates an embodiment of reinforced tubing for use with anintra-vaginal device.

FIGS. 46A-F illustrate embodiments of removal features of intra-vaginaldevices.

FIGS. 47A-B illustrate an embodiment of an intra-vaginal devicecomprising dampening properties.

FIGS. 48A-C illustrate an embodiment of an intra-vaginal devicecomprising adherence features.

FIGS. 49A-E illustrates an embodiment of a dampening mechanism.

FIGS. 50A-B illustrates an embodiment of a dampening mechanism.

FIGS. 51A-B illustrate an embodiment of an applicator for anintra-vaginal device.

FIGS. 52A-B illustrate an embodiment of an applicator for anintra-vaginal device.

FIGS. 53A-B illustrate an embodiment of an applicator for anintra-vaginal device.

FIGS. 54A-C illustrate an embodiment of an applicator for anintra-vaginal device.

FIGS. 55A-B illustrate an embodiment of an applicator for anintra-vaginal device.

FIGS. 56A-C illustrate an embodiment of an applicator for anintra-vaginal device.

FIGS. 57A-C illustrate an embodiment of tearable sheath for use duringintra-vaginal device insertion.

FIGS. 58A-B illustrate an embodiment of a cap that can be used forintra-vaginal device handling and insertion.

FIGS. 59A-E illustrate an embodiment of a tool for controlling andpositioning an intra-vaginal device.

FIGS. 60A-C illustrate an embodiment of a tool for controlling andpositioning an intra-vaginal device.

FIGS. 61A-B illustrate an embodiment of a mechanism for holding anintra-vaginal device.

FIGS. 62A-C illustrate an embodiment of a sheet that can be used forholding an intra-vaginal device.

FIGS. 63A-B illustrate an embodiment of a sheet that can be used forholding an intra-vaginal device.

FIG. 64 illustrates an embodiment of inflation tubing.

DETAILED DESCRIPTION

The disclosure herein relates generally to intra-vaginal devices andmethods for controlling the passage of stool. The devices are adapted toat least partially occlude the rectum to control the passage of stoolwhile remaining stable inside the vagina.

Extensive human clinical trials were performed in order to understandkey attributes for devices that will achieve the desired vaginal bowelcontrol (VBC). First, the ability for users (patients and clinicians) toeasily insert and remove the device is a priority for successfultreatment. If patients cannot manage the use of the device, it cannot beused to control the passage of stool. Second, the ability to achieverectal occlusion was found to be influenced by a variety of designfeatures that were unanticipated from knowledge of the anatomy. Third,the stability of the device not only during rectal occlusion but alsowhen the device is not occluding the rectum turned out to be a keyaspect of device function and required specific adaptations to ensurethe device is stabilized when it is not occluding and when it isoccluding. Finally, the devices have to be adapted to interact with thetissue in a way that is comfortable and safe to the user while achievingocclusion and stability. Through bench and human clinical testing, thesediscoveries of how device design impacted device performance includingrectal occlusion, device stability, and user safety and comfort, led tothe development of inventive and effective vaginal bowel controldevices.

Exemplary intra-vaginal devices and methods are described in U.S.Publication No. 2013/0150661 (application Ser. No. 13/625,683), filedSep. 24, 2012, entitled “INTRA-VAGINAL DEVICES AND METHODS FOR TREATINGFECAL INCONTINENCE”; U.S. Publication No. 2013/0138135 (application Ser.No. 13/679,484), filed Nov. 16, 2012, entitled “INTRA-VAGINAL DEVICESAND METHODS FOR TREATING FECAL INCONTINENCE”; U.S. Publication No.2013/0144112 (application Ser. No. 13/679,528), filed on Nov. 16, 2012,entitled “INTRA-VAGINAL DEVICES AND METHODS FOR TREATING FECALINCONTINENCE”; International Publication No. WO 2011/116108 (Int'l. AppNo. PCT/US2011/028691), filed on Mar. 15, 2011, entitled “INTRA-VAGINALDEVICE FOR FECAL INCONTINENCE”; and International Publication No. WO2013/044239 (Int'l App. No. PCT/US2012/056923), filed Sep. 24, 2012,entitled “INTRA-VAGINAL DEVICES AND METHODS FOR TREATING FECALINCONTINENCE”, the disclosures of which are incorporated herein in theirentireties. These applications will herein be referred to collectivelyas “Earlier Applications”.

Collapsible Devices

Vaginal devices can be used for many applications, including fecalincontinence, urinary incontinence, pelvic organ prolapse, other bowelcontrol issues such as IBS, administration of hormones andpharmaceuticals, control of bleeding, physical therapy, and control ofmenstrual flow. In order to aid in insertion and removal from thevagina, some vaginal devices can be elastically deformed for insertionand removal, but require a user to continually apply force as the deviceis inserted. This can be difficult for the user and can result in anuncomfortable sensation when the device returns (usually quickly and viaspring force) to an un-deformed state. Similarly, when being removed,the vagina provides the force to deform the device to a smaller profile,which can be uncomfortable for the user (or the device is removed in itsun-collapsed shape). Often, a patient is using her hands to manipulatethe device into a smaller profile for insertion. It can be difficult forthe user to hold the device in this manner for insertion and to reachthe device for removal. Additionally, it can be difficult to control therelease of the device in order to avoid the uncomfortable sensation ofit opening once it is inside the vagina.

It can be important for such devices to strike a balance in which thedevice is easy enough to deform for insertion and removal, but hasenough structural integrity to maintain its appropriate position andwithstand anatomical forces, as well as additional forces such asextension of an integral portion of the device. In particular, a devicefor fecal incontinence can have an extendable portion that changes froma less extended state to a more extended state, extending posteriorlyagainst the rectovaginal septum. For this extension to be effective inpreventing unwanted passage of stool, it can be important for the deviceto maintain its position and support the extended portion, ensuring itextends posteriorly. Additionally, it can be important for the force ofstool against the extended portion (the force being transmitted throughthe rectovaginal septum) to be resisted by the device in order for thedevice to be effective at preventing unwanted passage of stool; this isalso true for a device with a statically extended portion.

Collapsible intra-vaginal devices to inhibit the passage of stool aredisclosed herein. In general, the collapsible intra-vaginal devices canbe opened from a collapsed state to a stable open state (e.g., forstabilizing the device after positioning in the vagina) and optionallyre-collapsed (e.g., for allowing easier insertion and removal of thedevice after positioning from the vagina). The intra-vaginal devicesdescribed herein include at least one extendable portion that can beextended against the rectovaginal septum to create a protrusion into therectal space and inhibit the passage of stool. More particularly, thedevices disclosed herein generally have a stabilizing body (orstabilizing portion) that maintains position and stability of thedevice, and an occluding body (or occluding portion) that can protrudeinto the rectal space. The occluding portion can be similar to theoccluding portions described for example in Earlier Applications.

The device can include an integral locking mechanism which has at leasttwo states. In one state, it allows the device to assume a state whereit is more rigid than another state in which it is less rigid. In thisway, the locking mechanism enables the device to switch between states.The more rigid state is preferred when the device is in an openconfiguration. Herein, device “rigidity” describes a resistance to grossdeformation. In many embodiments, this is particularly resistance togross out-of-plane deformations of the generally planar structure, andresistance to gross collapse in any direction within the plane of agenerally planar structure. The overall device is preferably soft andcan accommodate small amounts of deformation that do not upset theoverall stability of the device.

The states described above regarding the rigidity of the device and thegeneral nature of the locking mechanism can independently or separatelyapply to: the device as a whole, the stabilizing portion, the occludingportion, or a combination thereof.

The direction of device expansion when switching from a collapsed stateto an open state can be perpendicular to the direction of the extendableportion. In some embodiments, the expansion of the device from acollapsed state to an open state does not involve an expansion of thedevice in directions that are not perpendicular to the direction of theextendable portion. This near-perpendicular angle allows maximumpotential occlusion depth of an extendable portion of a given size.Additionally, configuring the device with the angle of extension nearperpendicular reduces the tendency for the device to translate insidethe vagina upon expansion.

In some embodiments, the stabilizing portion expands to a width that isgreater than the width of the extendable portion. A wider stabilizingportion can provide a more stable configuration of the device when theextendable body is extended. An extendable body of a smaller dimensioncan allow the extendable body to press into the rectum to an effectivedepth, while a patient remains comfortable. It was discovered thatreducing the width of the extendable body relative to the stabilizingbody increased vaginal slack in such a way that allowed for moreeffective posterior compression of the rectum through the vagina, whilemaintaining stability.

In some embodiments, the device can allow for collapse, and whencollapsing forces (e.g. fingers) are removed, it re-opens or partiallyre-opens on its own, or is re-openable with the application of externalor internal forces (e.g. inflating balloon, spring, engaging a lock). Itcan re-open to a stable state, or additional inputs can be required tore-stabilize (lock) the device in a stable open state.

Referring to FIGS. 1A-1C, an intravaginal device 10 for controllingfecal incontinence includes a collapsible stabilizing body 3 with acollapsible frame 12 and an expandable body 14 configured to extendposteriorly against the rectovaginal septum. The frame 12 is formed ofmultiple rigid segments (e.g., 4 segments, 6 segments, 8 segments, 10segments) that are joined at their ends by hinges that allow one-degreeof freedom of angular motion. In some cases, the rigid segments can bearcuate. Opening and collapsing the rigid segments allows the device toassume a generally round (e.g., oval or circular) open state during useafter insertion into the user's vagina and to assume a collapsed stateduring insertion and removal. The shape (round, oval or circular) of theopened device can be important for safe and effective functioning,providing support at minimal risk to vaginal tissue under repeatedextensions of the extendable body. In some cases, the rigid segments arepartially arcuate and partially linear in the open state.

Clinical testing revealed a range of pressures internal to the deviceand applied to the rectovaginal septum that were optimal for occludingthe rectum in order to prevent stool leakage, while at the same time notcausing discomfort or adverse events such as tissue necrosis. In someembodiments, the expandable body is inflated to a pressure of less thanabout 200 mmHg. In some embodiments, the expandable body is inflated toa pressure between about 40 mmHg and about 150 mmHg. In anotherexemplary embodiment, the expandable body is inflated to a pressurebetween about 60 mmHg and 120 mmHg.

In some embodiments, the expandable body applies a pressure of less than200 mmHg to the rectovaginal septum in an extended state. In someembodiments, the expandable body applies a pressure between about 40mmHg and about 150 mmHg to the rectovaginal septum in an extended state.In some embodiments, the expandable body applies a pressure in the rangeof about 60 mmHg to 120 mmHg to the rectovaginal septum in an extendedstate.

In some embodiments, the expandable body is located more than 2 cm fromthe distal end of the device. In some embodiments, the expandable bodyis located on the proximal half of the stabilizing portion. Throughhuman clinical testing, it was more difficult to obtain intravaginalrectal occlusion with the same posterior force application in the areaof the perineal body than in the area proximal to the perineal body.This result was unanticipated because the rectal canal is narrower inthe region of the perineal body. Users also felt greater discomfort whenforce was applied to the perineal body as compared to proximal to theperineal body. Locating the expandable body at least 2 cm from thedistal portion of the stabilizing body, and more preferably on theproximal half of the device, configures it to compress proximal to theperineal body.

In some embodiments, the expandable body compresses the rectum greaterthan about 3 cm proximal to the introitus. This configuration allows theocclusive portion to press proximal to the perineal body.

The segments are held in the open state via a locking mechanism 16 thatis engaged to secure the device in the open state during use. Ingeneral, the expandable body 14 is positioned above one or more segmentsof the frame, such that it is attached to a location on the stabilizingbody where the frame 12 is underneath it. Placing the expandable body 14above frame 12 can provide one or more of the following advantages:locating the expandable body in the proper anatomical location;providing sufficient support for the expandable body to ensure that itextends posteriorly against the rectovaginal septum rather thanextending anteriorly or in another direction; reducing the amount ofdevice components and material within the loop formed by the frame, sothat collapsibility for the frame is maximized (e.g., as compared tolocating the expandable body and its support largely within the loopformed by the frame such that it is compressed or pushed above or belowthe frame for collapse); reducing the need for additional structure tosupport and stabilize the expandable body; locating the balloon on thestabilizing body where the stabilizing body is less wide than anotherpart of the stabilizing body. The stabilizing body 3 is configured forsecuring the device around the area of the pubic notch and posteriorfornix and for supporting a force-applying or occluding body 14. FIG. 1Aillustrates the expandable body 14 partially deflated, while FIG. 1Billustrates the expandable body 14 inflated, in a force-applying state.FIGS. 1D and 1E illustrate another embodiment of the device 10, whereinthe locking mechanism 16 is more visible.

Herein, “Anterior” refers to portions of the device and anatomy closestto the bladder. Additionally, “Posterior” refers to portions of thedevice and anatomy closest to the rectum.

The expandable body 14 is a force applying or occluding portion. Theexpandable body can be an inflatable member such as a balloon, thoughother mechanisms are considered below. It can alternately be referred toas an extendable body or extendable portion.

The inhibition of stool resulting from the application of force is dueto the force the device applies to the rectum, which disallows thenormal expansion of the rectal lumen, which normally occurs toaccommodate stool. This action can be described as applying a force todeflect the recto-vaginal septum to compress the rectum, or as generallypreventing the expansion of the rectum by applying a force to it.Alternatively, the force applying portion can reversibly apply a forceagainst the vaginal wall opposite of the recto-vaginal septum, whichwould prevent stool passage by pressing the stabilizing body, or anadditional expandable member, against the rectovaginal septum.

The width of the expandable body can be about 1-6 cm, or about 3-5 cm.The length of the expandable body can be about 1-6 cm, or about 2-5 cm.The main body proximate to the expandable body can be less than about 7cm and more preferably less than about 5 cm in width to reduce tensionin the vaginal walls.

It can be important that the intra-vaginal device 10 not utilize lateraldistention of the vagina for fixation when applying pressure to therectum to occlude stool. Devices with a wider body that take out theslack in the vagina walls, can make it difficult to utilize therecto-vaginal septum to occlude the rectum. Since the device createssignificant lateral distension on the adjacent wall, the wall loses itsredundancy and elasticity and is not easily manipulated by theexpandable portion. The intra-vaginal device 10 can take advantage ofthe vaginal redundancy to push on the rectum. In other words, sufficientslack is still present in the vagina once the device 10 has beeninserted, allowing the vaginal walls to be manipulated such that therectum is occluded. This configuration allows stability and comfortwhile providing the function of occluding the rectum.

In the embodiment of FIGS. 1A and 1B, the stabilizing body (comprisingthe collapsible frame 12 and a soft encasement 11) forms a structuralperimeter. This structural perimeter can be rigid in the open state toresist deformation in out-of-plane directions, as well as resist awidth-wise or length-wise in-plane collapse. This perimeter, comprisingthe frame 12 of interconnected segments, is constrained to planar motionby the hinges joining the segments. Such rigidity of the structuralperimeter can be provided by the components that form the structuralperimeter itself (e.g. interconnected frame 12), as opposed to havingsupport features such as cross-bars or tension elements that span theopen space within the perimeter. In some embodiments, this rigidity andresistance of out-of-plane bending can limit the out-of-plane bending to≤about 30° under a load (e.g. about 1.5 lb) applied to periphery offrame, normal to plane of frame.

In some examples (e.g. FIGS. 1A, 1B, 1E), the expandable body 14 ispositioned on the periphery of the round shape formed by the frame 12 ata location that is approximately opposite the locking mechanism 16. Thisposition can allow for the expandable body to be in the properanatomical position (towards the proximal or deepest, portion of thevagina, towards the rectum), while also allowing the locking feature 16being in the anatomical location that is most readily accessible fromoutside the vagina for actuation (towards the distal portion of thevagina, centered at the introitus). Additionally, with the expandablebody 14 in this position, there is spatial clearance between it and thelocking mechanism 16, such that mechanisms and supports related to theexpandable body 14 and the locking mechanism 16 can operate withoutinterference from each other.

To stabilize the expandable body 14, at least a portion of the frame 12(or some extension thereof) preferably passes below the expandable bodyor additional support features of the expandable body (additionalsupport features include the cushioning pad that the expandable portionis positioned on). In other words, in the viewing direction as shown inFIG. 1E, the frame 12 passes through the area of the expandable portion14. In general, the stabilizing body can be positioned with respect tothe expandable body so that the stabilizing body is in a position toprovide reaction forces to forces generated by or acted on theexpandable body.

When the frame is collapsed, as shown in FIGS. 1C and 1D, the devicetakes the shape of multiple oval segments. “Oval”, in reference to theshape of the collapsed device, describes the shapes as seen in FIG. 1D,which have a convex exterior profile on either lateral side, and alonger (longitudinally, along the proximal distal axis) than they arewide (laterally). Referring to FIG. 1C, in this collapsed state, thewidth of the frame 12 midpoint 6 of the lateral arms is narrower thanthe width spanned by the portions proximal and distal to the midpoint.Collapsing in this manner, the widest (laterally) portion of the framein the open configuration become the narrowest portion (aside fromeither end where the device terminates in a point) of the collapsedconfiguration. Space 13 can be left between the collapsed segments ofthe frame that can advantageously accommodate portions of the extendableportion and its support. This space 13 can allow for more compactcollapsing of the device 10. Additionally, the curved profile of thecollapsed device can provide approximately oval formations that providepreferred gripping features for the manipulation of the device forinsertion and removal. In a preferred embodiment, the approximatelengthwise midpoint 6 (FIG. 1C) of the collapsed structure is thenarrowest portion of the collapsed device. This point is also thelocation where the most leverage is possible for compressing/collapsingthe device (meaning the least amount of force is required to fullycollapse when manipulated at this point). This can serve theadvantageous purposes of: allowing a contoured grip at an optimalgripping and compressing location; allowing the wider proximal end ofthe device to be first inserted past the (typically) narrowest portionof the vaginal lumen (the introitus). Then, if there is a pause ininsertion and a release of the collapsing force (e.g. a change of fingergripping positioning in the case of a manual insertion), the device isat least temporarily stable. The introitus would have to further widento pass either the proximal or distal segment, and at this point therewill be the least amount of force transferred to the introitus due tothe maximal leverage on the frame at this point. It is noted that theintroitus is the portion of the vagina that is particularly sensitive todistention. As a result, this collapsed configuration which includesmultiple arcuate portions provides a more comfortable insertion.

A removal feature 15 is operably connected to the locking mechanism suchthat when the removal feature is actuated (in the current example, byapplying tension), the lock is released and the device is able to becollapsed for removal or insertion. Collapsing the device in theunlocked state can be done by pulling the hinge opposing the lockingmechanism and the hinge comprising the locking mechanism away from oneanother. For example, the locking mechanism can be unlocked by pullingon the hinge comprising the locking mechanism 16 in a direction awayfrom the posterior end 4 of the device 10. With the device unlocked, thedevice can be collapsed in the unlocked state by pressing the lateralsides together. For example pressing together the lateral midpoint 6(FIG. 1C) towards the same point on the opposite side of the device. Theremoval feature 15 can comprise a tensile element (e.g., a cord, cable,string, wire, etc.). This removal feature 15 preferably resides outsideof the vagina to facilitate removal (e.g. by pulling on a cord). In someexamples, the expandable body 14 is an inflatable balloon with aninflation tube 17 extending outside of the vagina. This inflation tubecan be coupled to the removal mechanism 15. In some embodiments, thetube itself, or a reinforced section of it, can be tensioned to releasethe lock (see, for example, FIG. 45 and its description).

The stabilizing body frame can be encased in a soft material 11, (e.g.silicone) to protect the vaginal tissue against the rigid portions ofthe device. There can preferably be additional soft material disposed 22(FIG. 1A), 28 (FIG. 1E) in the proximal portion of the device, proximateto the expandable body 14. Additional protective material (described inmore detail below) in this area can help protect against forceconcentrations due to the presence of or extension of the expandablebody, as well as protect against the proximal most leading edge of thecollapsed frame during insertion. This soft material can be flexible toaccommodate the shape changes of the frame. In some embodiments, noprotective material is used, for example, if the shape of the collapseddevice presents no sharp edges and the contours of the perimeter of theopened and collapsed device are without corners. In some embodiments,the device comprises multiple rigid segments. There can be some amountof flexibility to the rigid segments, but when deployed, they canprovide enough rigidity to support the device's function. These segmentsare joined by more flexible or disjointed portions in a number ofpossible ways. For example, multiple “segments” can comprise onecontinuous piece of material, where the more rigid segments areseparated by more flexible portions that allow some degree of foldingbetween the rigid segments. Alternately, the rigid segments can bejoined by a joint that allows relative motion between the rigidsegments. This joint can be, for example, a hinge, a ball-in-socketjoint, a living hinge (of the same, or dissimilar material as the rigidsegment), a connecting segment of more flexible material, or any othermeans of joining two or more rigid segments in a manner that allows somedegree of relative motion between the rigid segments. The device cancomprise similar joints between rigid segments, or different jointsbetween rigid segments. In a preferred embodiment, these joints areconfigured to constrain the relative motion to one-degree of freedom(e.g. one angular dimension). In the example of the living hinge, thiscan be accomplished by the geometry of the living hinge portion being aband that is wider in the direction normal to the plane of bending thanin a direction parallel to the plane of bending, thus making it easyflex in the plane of bending, and more difficult to flex in otherplanes.

Exemplary materials for the rigid segments include, but are not limitedto, stainless steel, polycarbonate, glass-filled polycarbonate, peek,acrylic, and delrin.

In some embodiments, as shown in FIGS. 2A-2D, a stabilizing body frame14 for the device is formed of 4 curved (e.g., arcuate) or partiallycurved rigid segments 32, 34, 36, and 38, joined at their ends by hingesthat allow one-degree of freedom of angular (e.g., rotational) motion(e.g., hinges 40, 42, 44, 46). In order to prevent twisting orout-of-plane motion between segments, the segments have flat faces atthe hinges (e.g. the opposing surfaces of each hinge is planar) and arepreferably constrained to have space between them that is less thanabout ⅛-½ the diameter of the axle, such that the hinges are moresecurely constrained to prevent twisting or out-of-plane motion betweensegments. The segments are arranged such that when they are allconnected end-to-end, they form a planar loop.

The use of curved segments (e.g. 32, 34, 38, and 36) has the additionaladvantage of allowing for the device to form a loop with a roundedexterior profile and a predominantly open center. Fewer than 4 curvedsegments can be used as well, including for example using only twocurved segments on the distal half of the device. Open space isadvantageous for allowing movement of vaginal fluids. Minimizing theamount of volume occupied by the device is also advantageous for vaginalhealth; both are improved by the use of curved members to support thestructural perimeter of the device by providing a rounded externalprofile and minimizing the material within the structural perimeter

The frame components (e.g. 32, 34, 36, 38), as well as the protectivesoft covering 11 (FIGS. 1A-1E), form a smooth outer profile, withoutcorners or sharp bends. The perimeter of the device, as well as theouter perimeter of the frame, when viewed in the anterior-posteriordirection, as shown in, for example, FIG. 1E has no arcs ≥about 20 mm inlength with radii of curvature less than about 12 mm; or no arcs ≥about10 mm in length with radii of curvature less than about 5 mm; or no arcs≥about 5 mm in length with radii of curvature less than about 3 mm. Inanother example, in the open configuration, at each hinge, an angledrawn to a points on the midlines of the adjacent frame segments at adistance of about 18 mm from the hinge forms an angle with the hinge≥about 100 but ≤about 180 degrees; or the angle formed by points onadjacent segment's midlines at a distance of about 14 mm from theirmutual hinge is ≥about 95 but ≤about 195 degrees; more preferably theangle formed by points on adjacent segment's midlines at a distance of10 mm from their mutual hinge is >about 90 but ≤about 210 degrees. Inanother example, both the limits described above on the radii ofcurvature and angles at the hinges must be true. In some embodiments,the device has no sharp or angled features, and includes tangencies orapproximate tangencies at all locations of flexure such as the locationsof the joints.

In some embodiments, with all 4 hinges joined, the assembly can take avariety of shapes including an open shape (e.g. as shown in FIG. 2A), ora collapsed shape, (e.g. as shown in FIG. 2D). FIGS. 2A-2D, illustratean embodiment of a frame 12 being collapsed. FIGS. 2E-2G illustrate anembodiment of the locking mechanism 16 in detail being unlocked as theframe is collapsing. In the collapsed shape, two opposing hinges (e.g.,hinges 40,44) approach each other, as shown in FIGS. 2C and 2D, whichshow the frame collapsing. Hinge 42 can be referred to as the proximalhinge. The proximal hinge 42, in-situ, rests near the cervix or vaginalcuff of a patient. The opposite hinge 46 is referred to as the distalhinge. The distal hinge 46 rests near the introitus. The other hinges40, 44 are referred to as lateral hinges. The device 10 is configured tocollapse via a “lengthwise collapse” wherein, during the collapse of thedevice the proximal and distal hinges 42, 46 move away from each other(e.g., the distance between the proximal and distal hinges 42, 46 isgreater in the collapsed position than in the open position), and thelateral hinges 40, 44 move towards each other (e.g., the distancebetween the lateral hinges 40, 44 is smaller in the collapsed positionthan in the open position). Considering overall widths and lengths ofthe device, during the collapse of the device, the length increases andthe width decreases. In some embodiments, the height of the device doesnot change during the collapsing or opening of the device.

As described above, and as shown in FIGS. 2A-2D, the hinge pattern issymmetric about an axis (a line drawn from hinge 46 through hinge 42).However, other configurations are possible as well. For example, FIGS.3A and 3B illustrate an embodiment of a hinge pattern that is symmetricabout a point or rotationally. FIGS. 3C and 3D illustrate anotherembodiment of a hinge pattern that is symmetric about a point orrotationally. These configurations can be more compact widthwise thansymmetrical ones in the collapsed configuration or offer differentleverages for control of the device during insertion and removal.

FIGS. 2E-2H shows an exemplary locking mechanism. The collapsible frameof a preferred embodiment locks when a latch 48 that is attached to oneframe segment 34 drops into a pocket 50 on another frame segment 32.When lateral force is applied to the device, the latch prevents thesegment 32 with the pocket 50 from rotating with respect to the othersegment 34, preventing collapse. When the latch is rotated out of thepocket, segment 32 is allowed to rotate with respect to segment 34, andtherefore the device can collapse. The pocket and latch are constrainedto interact by being maintained in the same plane, in this example bybeing sandwiched between other segments of the frame and by their pivotpoints being a fixed maximum distance from one another. FIG. 2Hillustrates the latch 48 and pocket being sandwiched in between portionsof segment 34. As segment 32 rotates about hinge 46, the face 52 of itspocket 50 that faces the latch presses against the latch face,transmitting a force to the hinge 49 of the latch. The latch-facingsurface of the pocket and the pocket-facing surface of the latch havecurved faces 52 that are concentric with each other and with the pivotpoint 49 of the latch 48 so that as the latch is moved, its advantagerelative to the pocket does not change until a point 51 is reached,where the radius of the latch's face decreases and the segment with thepocket can slide past the latch, allowing segment 32 to rotate, andtherefore allowing the device to collapse. In other words, one advantageof the concentric faces is that the latch rotates free of interferencefrom the pocket (other than friction at the surface). If the faces ofthe latch and the pocket are not concentric with the latch's pivotpoint, the lock can become unstable. For example, if the curvature orangle of the pocket's face is shallower than the curvature or angle ofthe latch's face, when segment 32 rotates, the pocket 50 can push latch48 up and out of the way, unlocking the lock. Alternately, if the pockethas an overhang with respect to the latch, the pocket face will have tobe moved away from the latch to allow the latch to be clear to rotateout of the pocket; and since moving the pocket in this fashion requiresclockwise rotation of 32, and rotation in this direction causes theoverall device structure to become laterally wider, disengaging the lockwhen there is an overhang over the latch will therefore be difficult ifthere is any force resisting a widening of the device. Such a forcecould be anything pushing laterally inwards on the device (e.g., thevaginal walls pressing against the device). This is a particularlyimportant factor for a vaginal device as there could be a lateral loadapplied to the device by the vaginal walls when it is wished to beremoved.

In the latch embodiment shown in FIG. 2E-2G, the segment 32 with thepocket 50 has a curved region 54 that remains engaged with the latch inthe collapsed state so that upon opening of the device, the latch 48presses against the curved region as 32 rotates until the pocket 50becomes aligned with the latch, and the latch drops in. A member (inthis case spring 56) is used to provide the force for dropping the latchinto the pocket. The tail of the latch 48 that the spring pushes on iscurved so that the latch can move smoothly relative to the spring duringcollapse and opening of the device. The latch tail 61 comprises anelement such as a pull cord attached. The length of the tail 61increases the advantage of the user against the friction of the matedsurfaces. When pulled, the latch rotates until the tail reaches a hardstop 60, transferring further force directly to the device frame,facilitating removal.

As described above, a force applied to the device in a way that cancause the device to collapse will transmit force to the lockingmechanism or mechanisms. In the example provided above (FIG. 2E-2G),this results in friction between the mated surfaces at 52. This force orpressure transmitted to the locking mechanism 16 can make it moredifficult to actuate. This is true of many lock designs. As describedabove, the concentric faces at 52 minimize this effect. The effect of acollapsing force on a locking mechanism can also be referred to asbinding. Another means of reducing the binding in a locking element isto provide for some springiness in at least one of the locking segments(e.g. segments 32 or 34). For example if either (or both) of 32 and 34had some flexibility, they could flex when pressed on by for example thevaginal walls or fingers, transmitting less force to the lock andresulting in less binding.

Alternately to the use of a spring, the material surrounding thecollapsible frame (especially when an elastomeric material) can push thelatch back into position. Any number of configurations of springelements can be used to return the latch to the mated position. Thelocation of the lock and lockable hinge 46 can be offset to one sidesuch that if a tensile element is used to rotate the latch, it isapproximately centered to the device.

In general, a locking mechanism similar to the example described aboveoperates by preventing rotation of at least one segment of a hinge in atleast one direction. This can be accomplished by a number of meansinvolving a removable obstruction to the motion of at least one segment.Typically the feature that causes the obstruction is affixed to theopposite segment, but it can also be affixed to a different portion ofthe device or a third member. Additional locking mechanism examples aredescribed below.

In some embodiments, when the device is not in the locked open state,the device (absent external forces) can naturally be in a state that isalmost locked, such that only a small amount of force or displacementcauses the device to be locked. In this way, it is not difficult to lockthe device once it is inserted into the vagina. For example, asdescribed in more detail above, the mechanism shown in FIGS. 2A-2G lockswhen latch 48 drops into pocket 50. When segments 32 and 34 rotate froma collapsed configuration to the open configuration, a point is passedwhere latch 48 is able to drop into pocket 50; the frame is then locked.Therefore, the overall configuration of the stabilizing body can be suchthat, at rest, the latch 48 is very close to the pocket 50, such that asmall amount of further opening causes it to latch. Alternately, thestabilizing body can be biased such that there are spring forces (e.g.provided by the encasement material, expandable portion, expandableportion support, springs, or resiliency of segment joints) that tend tomore fully collapse the stabilizing body. In this way, these forces areovercome to open and lock the stabilizing body. Alternately, thestabilizing body can be biased to fully open to or past the point oflocking, such that (absent other interfering forces) when collapsingforces are released, the stabilizing portion opens and locks. In thisway, these spring forces are overcome to collapse the device. It can bepreferable to have the device configured such that minimal force isrequired to change the state of the device from fully locked to open tocollapsed.

Preferably, the protective covering is flexible enough to accommodatethe motion of mechanisms involved in lock and unlocking a joint orjoints. Additionally, space can be provided between the mechanism andthe protective encasement to further allow movement of these mechanisms.

In another embodiment, no latching mechanism is necessarily used tosecure the device in a given position. Instead, spring force can be usedto cause the device to be biased towards a given shape. In thisconfiguration, there is still an advantage to having the shape change ina constrained manner as described above (e.g. utilizing segments withconstrained hinges). As described herein, the constrained, generallyplanar motion of the shape change is easier to handle. Additionally, theadvantages described above regarding structural integrity (resistance toout-of-plane folding) and expandable body support apply to thisconfiguration as well. An additional advantage of this design is that itcan self-adjust to a particular length or width to fit a patient'sanatomy because it opens under spring force until it meets externalresistance (or maxes out its springs); in this way it can expand untilit presses hard enough against the vaginal walls for the spring force tobe balanced. Furthermore, if a force directed along the proximal-distalaxis (such as pressure from the proximal vagina) causes the proximalhinge (FIG. 2A, 42) to move towards the distal hinge (FIG. 2A 46), thekinematics of the 4 bar linkage will cause the device to become wider,reducing the potential for the device to slip out of the vagina. This ispossible for other numbers of linkages as well.

The above descriptions (e.g. descriptions of the device of FIGS. 1A-1E,2A-2G) are not meant to exclude other number of joints or configurationsof joints wherein one or more joints allow for greater than one degreeof freedom. For example, a single joint with multiple degrees of freedom(e.g., a ball and socket joint) will still allow for the full assemblyto maintain planar constraint, especially if the remaining joints haveonly one degree of freedom (preferably rotational). Two adjacent jointscan also have multiple degrees of freedom, which can allow the segmentspanning them to move (e.g., rotate) relative to the rest of the frame.If the rest of the frame is constrained, the overall stability can bemaintained. However, it can be advantageous to limit the amount of playand relative motion of the stabilizing frame to enable a securepositioning of the expandable body against the rectovaginal septum suchthat the expandable body and the device as a whole can resist a loss ofposition based on forces from the anatomy and stool passage. One way ofdoing this is to have at least 3 hinges constrained to a single degreeof freedom; preferably rotational. One or more joints between segmentsof the frame can be formed not by a rigid hinge, but by encasing twoadjacent segment ends in an elastomeric material or bonding them to anelastomeric material.

In the collapsed position, the curvature of the segments (e.g., segments32, 34, 36, 38) forms a non-linear collapsed frame. More particularly,in the collapsed position (as shown in FIG. 2D), the frame formsmultiple approximately round or oval shaped segments 62. Collapsing intoa set of round or oval shaped segments is believed to provide theadvantage of providing space between opposing sides of the device inwhich portions of the device related to the extendable portion (e.g.padding, balloon, tubing connections, supports) can reside in thecollapsed configuration. FIG. 1D shows expandable body 14 and cushioningmember 22 inside of space 13. This orientation can allow for a morecompact collapsed form, with less interference to folding from theextendable portion. Additionally, it can allow these other components ofthe device to be situated in the same plane as the rigid segments,instead of above or below their plane, such that the overall height ofthe device is not increased, either in the opened or collapsed state.Additionally, the oval or round segments can provide gripping structurefor the user that allows for better control, particularly forcontrolling against rotation (e.g. with a wider structure to grasp, thecollapsed device is less likely to slip, in a rotating fashion).

More generally, in the collapsed configuration, there can be spacebetween the approximate midpoints of opposing proximal segments (e.g.,segments 32 and 34, FIG. 2D) and/or distal segments (e.g., segments 36and 38, FIG. 2D) that can accommodate other features of the deviceduring collapse. In some embodiments, this space can be less than ½ andat least about 1/15 the nominal external lateral width of the openconfiguration during use; or, this space is about 1/10 the nominalexternal width of the open configuration during use; or, this space isat least about ⅛ the nominal external width of the open configurationduring use. In some embodiments, this space is less than about 25 mm andat least about 6.5 mm; or, this space is at least about 6 mm; or, thisspace is at least about 5 mm. On the distal end, open space extends toat least about 6.5 mm (or about 6 mm; or about 5.5 mm; or about 4.5 mm)distal of the widest portion. The distal space can allows a fingerholdfor control during insertion and since it is distal to the widestportion, allows the widest portion to be inserted into the vagina beforethe user wishes to change grip. During removal, this fingerhold can beclose enough to the vaginal opening to be accessed, and can be used topull on the device. As shown in FIG. 2D, the distal portion (formed bysegments 32 and 34) of the collapsed configuration forms a tapered tipof about 10-135° (or about 20-90°); said angle continuing for a distanceof at least about 0.5″ from the distal tip. In some embodiments, thetapered tip can form an angle of about 10-35°. The taper can allow theuser to squeeze and push the device at the same time. The distal portionof the collapsed device (formed by segments 32 and 34), when includingthe soft material that covers the frame, can be at least about 2×-3× aswide, laterally, as the height (in an anterior-posterior direction).This width can provide structure to grasp, making the collapsed deviceless likely to slip in a rotating fashion while being held. Thisstructure can be important as correct orientation of the device in thevagina is important for correct use, and in the process of insertingvaginal devices, especially with the use of lubrication, can cause thedevice to rotate or flip. The collapsed configuration is narrower at itsapproximate midpoint, where the two lateral hinges 40, 44 of the frameare positioned. The external width of the device at this midpoint isabout 6 mm narrower than the wider portions proximal and distal to it,providing a location for a firm grip if the device becomes slipperyduring insertion, as is often the case when lubrication is used. Inanother embodiment of the device, shown in FIG. 4, a feature or features64 extend at least 2-5 mm from the frame, and are located about 0-10 mmalong the length of segments 32 and 34 from their mutual connectingpoint. These features 64 can further enhance grip on the tapered portionof the collapsed device. These features can be extensions of segments 32and 34 themselves, being comprised of the same rigid material and beingof the same solid part. Alternately, they can be part of the soft outermaterial (e.g. silicone).

Referring back to the examples shown in FIGS. 2A-2G, on one hinge (e.g.,hinge 46), there is a mechanism 16 for locking that hinge 46 such thatthe angle between lines drawn from it to its two adjacent hinges isfixed, or at least fixed in one angular direction. In a preferredembodiment, the lock 16 is on the distal hinge 46 and is configured suchthat, when locked, the lateral hinges 40, 44 are not able to movetowards each other, and thus the angle formed by the distal hinge(defined as the angle, facing the proximal hinge, formed by the linesdrawn from the distal hinge to its two adjacent hinges) cannot becomesmaller. In another embodiment the lock on hinge 46 also prevents thelateral hinges 40, 44 from moving away from each other. This is in partdue to the resilience of the segments 32, 34. If segments 32, 34 aresomewhat flexible, some motion of hinges 40, 44 is possible, even withhinge 46 locked. Some amount of motion of these hinges can be preferablein certain situations when an overall lateral or proximal-distalflexibility is desired. In this case, these segments (or at least one ofthem) alone or in conjunction with one or more of the distal segmentscan be somewhat flexible.

Referring to the examples of FIGS. 1A-1E, the rigid segments aregenerally shaped to follow the contour of the edge of the full deviceincluding any soft covering material (e.g., soft material 11). However,as shown in FIG. 1E, in the open shape, the rigid segments 36, 38 thatform the proximal hinge can depart from the external profile of thedevice, turning more inward to form a generally straight portion that ispositioned beneath the extendable device. More particularly, segments36, 38 include a curved portion and a straight portion. This departurefrom the external profile of the device can allow for a greater distancebetween the proximal hinge 42 and the exterior surface of the device andfor more soft material between the rigid proximal hinge 42 componentsand the vaginal tissue near or at the cervix or vaginal vault. Forexample, the soft material surrounding segments 32, 34, and the curvedportions of segments 36, 38 can extend about 0.5-10 mm from the framewhile the soft material surrounding the generally straight portion ofsegments 36, 38 near hinge 42 can extend about 3-20 mm from the frame.In another example, the thickness (shown by arrow 5 in FIG. 1E) betweenthe edge of the frame and the edge of the soft material proximal to theproximal hinge is at least about the same as the thickness of the softmaterial surrounding the segments on the distal side of the device; orat least about 1.5 times greater; or at least about 2.5 times greater;or at least about 4 times greater. Additionally, this configuration canallow for the thickness of the soft material proximal to the proximalhinge to be approximately as thick as the thickness of the soft materialanterior to the proximal hinge; or more preferably, about ≥1.5 times thethickness; or more preferably, about ≥2 times the thickness. Providingextra room for soft material is especially advantageous considering thatwhen the device is folded, the angle formed by the proximal hinge 42becomes more acute which can create a point, directed posteriorly (asshown in FIG. 1D), and the added soft material helps protect the vaginalwalls from this point. This configuration of the proximal hinge 42 canalso better align the support structure of the rigid segments with theexpandable body to secure the expandable body in the proper position.

The straight (e.g. linear) portion of the segments 36, 38 (FIG. 1E) thatform the proximal hinge, as described above need not be perfectlystraight. The segments 36, 38 can be curved or angled. The segments 36,38 can, in some way, deviate away from the outer edge of the device'sprotective encasement or any cushioning material that forms the externalperimeter of the device, in this way providing for a greater amount ofcushioning material and/or deviating to support the expandable body inthe proper location with respect to the exterior dimensions of theoverall device. However, depending on the desired shape of the deviceperimeter, the segments 36, 38 can also be rounded as shown in FIGS. 7Aand 7B, which show an embodiment of the device 10 in an openconfiguration and a collapsed configuration, respectively. In thisembodiment, there is a continuous tangency along the edge of segments 36and 38, without deviations from a smooth curve. Placement of thissupport for the expandable body 14 can be biased proximally or distallyto the geometric center of the expandable body 14. As shown in FIGS. 7Aand 7B, the support is biased proximally, providing less support to thedistal extent of the expandable body.

In some embodiments such as in the examples of FIGS. 1A-1E, there is abroad lateral support for the extendable portion provided by thestabilizing body. In a particular embodiment, the path of the framesegments 38, 36 that support the expandable body 14 provides support forthe expandable body against the expandable body tilting or movinglaterally. In other words, if a lateral force is applied at somedistance along the extension direction of the expandable body, the forcewould cause the expandable body to deviate in a translating or angular(tilting) fashion; preferably, the frame segments stabilize theexpandable body against this deviation. In general, broad lateralsupport for the expandable body can help to stabilize the expandablebody in the appropriate position in the vagina, ensure that theexpandable body extends in an appropriate direction (posteriorly, andgenerally perpendicular to the plane of the stabilizing body), andstabilize the expandable body against forces encountered during useincluding the force of stool pressing against the protrusion in therectum created by the expandable body, resistance in the vaginal wallsto the extension of the expandable body and other internal body forcessuch as coughing or sneezing.

For example, FIG. 1E shows the frame segments 36, 38 spanning the widthof the expandable body 14, crossing the expandable body at approximatelyits widest lateral span. Thus, a solid supporting structure of the frameextends across and underneath the entire expandable body 14 at thelocation where the expandable body 14 is the widest. For example, if theexpandable body comprises a substantially circular cross-sectionalshape, the expandable body can be disposed such that the frame islocated underneath a line that bisects the circular shape into twosemi-circular shapes. In another example, if the expandable body issubstantially elliptical in cross-sectional shape (with the major axisarranged laterally), the expandable body can be disposed such that theframe is located underneath the major axis of the ellipse. If theexpandable body is substantially rectangular in shape, the expandablebody can be disposed such that the frame is located underneath a linethat bisects the rectangle into two approximately equally shapedrectangles. In general, if a point were made in the plane of the deviceas viewed in FIG. 1E (e.g. showing a view from anterior to posterior),and that point represented the location of the center of mass of theexpandable body, the frame can pass through this point, movingrelatively linearly from one lateral side to the other. In this way, theframe can provide optimal leverage against lateral tilt. In someembodiments, the frame segments cross the outline of the expandable body(the outline of the expandable body as it is attached to the stabilizingbody; for example: circle 7 in FIG. 1E) near the midsection of theoutline. The frame can enter this outline at an angle ≤45° with thelateral axis; the frame can enter this region at an angle ≤20′; theframe can enter this region at an angle close to 0°. The location ofthis angle is shown at 9 in FIG. 1E; the angle at 9 is 0°. Someembodiments comprise frame segments that traverse the region of theexpandable body near the midsection of intersection of the expandablebody (or any supporting feature of the expandable body) and the plane ofthe frame. In some embodiments, the frame, on average, traverses thisregion at an angle ≤about 45° with the lateral axis; or, the frame, onaverage, traverses this region at an angle ≤about 20°; or, the frame, onaverage, traverses this region at an angle close to 0°.

There can be an advantage to attaching the expandable body to twoadjacent segments of the stabilizing body. In some examples, such asthat shown in FIG. 1E, this places the hinge 42 underneath theexpandable body. In the embodiment shown in FIGS. 1A-1E, the expandablebody 14 is connected via the encasement material 11 and soft portions28, 22 to two segments 36 and 38 of the stabilizing body. The portionsof segments 36 and 38 furthest from their mutual hinge 42 travel thegreatest distance during collapsing and opening. Therefore, it can beadvantageous for the attachment between the expandable body and thesesegments to occur as close to their mutual hinge as possible, so thatthere is less requirement for the expandable body, or its support (e.g.encasement material 11 and soft material 22 and 28), to have toaccommodate the travel distance of the segments. In other words, keepingthe expandable body and its support close to the hinge limit the amountthat they have to be squeezed or stretched to accommodate the openingand closing of the frame 12. It can also be advantageous for the widthof the attachment of the expandable portion to be less than the maximumlateral width of the stabilizing portion. The importance of thisgeometric constraint is explained in Earlier Applications, as well asdescribed herein.

While in the example described above, the expandable body is disposedover a hinge, in some examples the expandable body is not disposed overa hinge. For example, FIGS. 8A and 8B illustrate an embodiment whereinthe expandable body is not over a hinge, but is instead located over arigid segment. In this embodiment, the device would have to be rotatedonce inserted and at least partially opened. Similarly, for removal, apull cord 66 can be used to re-orient the collapsed device such that thesmallest dimension is perpendicular to the proximal-distal axis of thevagina. The pull cord can optionally interact with a locking mechanismto disengage the lock.

Referring again to FIGS. 1A-1E and 2A-2G, the four rigid segments 32,34, 36, 38 joined by four constrained joints 40, 42, 44, 46 as describedabove, when locked (fixed), can provide the structural integritynecessary to carry out the function of extending an occluding bodyagainst the rectovaginal septum, such that the septum protrudessufficiently into the rectal space to impede unwanted stool passage. Itis important for the device to have enough structural integrity toensure the extension is directed posteriorly, rather than the extensionpushing the whole device anteriorly. As described in EarlierApplications, this is enabled by the interconnected frame engaging abroader area of vaginal tissue on the anterior side of the vagina. Asthe expandable body extends it creates a force that is directed equallyand oppositely against both the posterior vaginal wall and thestabilizing body. Because the stabilizing body is wider (laterally), andlonger (proximal-distally), it encompasses a much larger area of tissuewithin its perimeter. Therefore, when exposed to the force of theextending expandable body, the stabilizing body is less likely to moveas it would have to displace much more tissue. Additionally, the tissueengaged at the lateral and proximal and distal extents of thestabilizing portion (i.e. around the perimeter) is less likely to bemoved anteriorly as it is close to the vaginal sidewalls and so can'tdeflect anteriorly the way the anterior wall does, but would rather haveto stretch. As a result, the expandable portion extends posteriorlybecause it is more difficult to move the stabilizing portion anteriorly.However, if the stabilizing body could deform under the pressure of theforce of the expandable body (pressures and expandable body sizesprovided in Earlier Applications and herein), for example, by bowingsuch that the midline of the stabilizing body is moved anteriorly andthe lateral extents are pointed posteriorly, it would lose itsresistance to moving anteriorly as it no longer presses against theanterior wall as a flat surface, but rather a curved one, making thearea of tissue engagement smaller and the lateral extents of thestabilizing body not engaging the vaginal walls, but rather bending andconforming to them. It, therefore, can be important for the structuralintegrity of the device to ensure that the extension does not cause thedevice to bend or fold to the extent that the extension does not createa secure enough protrusion into the rectum to inhibit the unwantedpassage of stool. In addition, the structural integrity of the devicecan be sufficient to withstand any distally-directed force from theextension that can cause a device to collapse in-plane, or foldout-of-plane as the device is pressed against the interior surface ofthe vaginal opening, resulting in device expulsion. The structuralintegrity of the device can resist this by resisting the shape changesthat would allow it to be expelled. For example, if the device folded,like a taco, or like the bowing example provided above, it could becomenarrow enough to slip out of the introitus. Or, if the device narrowslaterally (as it does during collapse, e.g. shown in FIG. 1D) it couldalso slip out of the vagina. The planar stiffness of the stabilizingbody (resisting out-of-plane bending or bowing), and the lateralrigidity of the stabilizing body (resisting in-plane collapse) can helpprevent shape changes tending towards expulsion. The planar stiffness isaccomplished in the device of FIGS. 1A-1D and 2A-2G by using a framethat is comprised of rigid segments (e.g. 32, 34, 36, 38) that are stiffenough to resist substantial flexing under the loads of the expandablebody and body forces. These segments are interconnected by hinge joints(e.g. 40, 42, 44, 46) that allow only for in-plane rotational motionbetween segments. This interconnected frame therefore is configured toonly freely change shape (via changes in angles between segments) withinthe plane of the frame, and as a result cannot bend out-of-plane. Thehinges prevent any segment from lifting or dropping out of the planeformed by the other segments. The lateral rigidity (resistance tolateral collapse or in-plane collapse) is provided by the resistance ofthe individual segments to bending in-plane, and the fact that one ofthe hinges can lock. The 4 segments of FIG. 2A-2D form a 4-bar linkage.Locking only one hinge therefore turns the assembly into a 3-bar linkagewhich is constrained such that motion is not possible at any of thejoints, thereby preventing collapse. Therefore, in the locked state,when the device is squeezed laterally (for example by the narrowingvaginal walls as the device is being pushed anteriorly by a cough), theforce is transferred through the stiff segments, which do notsubstantially bend, to the joints, which are restricted from moving. Asa result, the device maintains its width and cannot slip out of thevagina.

As described above, and presented in FIGS. 1A-1E, this structuralintegrity can be provided by the structural perimeter itself. That is,there are no cross bars, tension elements, or other structural elementsthat span across the perimeter to provide in-plane and out-of-planestiffness. Instead the stiffness is provided by the rigidity of thesegments and the constraint of the joints. It can be advantageous toprovide rigidity in such a way devoid of structural elements spanningthe perimeter formed by the interconnected frame. Some of the advantagesof not having structural elements spanning the perimeter include: morespace for collapse and less material inside the vagina.

As noted elsewhere in this application, the concept of an interconnectedframe that provides structural integrity to the stabilizing body andalso allows for collapse is not limited to only the embodimentsdescribed above, comprising 4 rigid segments and 4 constrained hinges.For example, if one of the 4 joints 40, 42, 44, 46 of FIG. 2A weredisconnected or not constrained to only 1-degree of rotational motion,the overall interconnected frame would still only change shape withinthe plane of the frame because all segments would still have at least 1joint that is constraining it to planar motion. Embodiments with morethan 4 segments are also described herein. However, all embodiments canbe configured to resist out-of-plane bending and lateral collapse asdescribed above to suit the needs of an intravaginal rectal occlusiondevice.

In some embodiments, the specific portion of the stabilizing body thatthe extendable portion is attached to can change between a state whereit has a fixed geometry, and a state where its geometry can change. Forexample, in FIGS. 1A-1C, this is accomplished by locating the extendableportion over the proximal hinge, which becomes fixed at a pre-definedangle when lock mechanism 16 is engaged (due to the fact that all otherframe segments are rigid and at least 3 of the hinges are constrained to1 degree of freedom of rotational motion), and is less rigid when thelocking mechanism is disengaged. As described elsewhere, the structuralsupport for the extendable portion is particularly important fortreating fecal incontinence. It can therefore be advantageous to havethe rigid characteristics of the frame extend in some manner to theextendable portion.

In a preferred embodiment, only one joint (e.g., joint 46) is locked toprovide the stability described above. To facilitate this, the segmentsare resilient, and the joints are sufficiently constrained to the motiondescribed above. If some of the segments or joints are not rigid orconstrained as described above, there will be more deformation of thedevice when acted upon by a force, which can inhibit the ability of thedevice to secure the expandable body against the forces of the posteriorvaginal wall and stool pressure. There can be advantages to utilizing asingle locked joint. For example, as described above, in a preferredembodiment, this lock is located on the hinge opposite the expandablebody. In this configuration, the locking mechanism is free from anyspace or folding constraints resulting from the expandable body.Additionally, this places the lock at the distal most (and thereforemost accessible) portion of the vagina, so manipulations needed forinteracting with the lock mechanism are best facilitated.

In a preferred embodiment as shown in FIGS. 1A-1C, the expandable body14 is located proximate to the periphery of the frame. The expandablebody is generally located proximal to the widest lateral portion of thestabilizing body, as described in Earlier Applications. Such aconfiguration can reduce the lateral stretch on vaginal tissue in thisarea when the expandable body extends posteriorly. Reducing the stretchin this area maintains slack in this region and allows the expandablebody to effectively extends towards the rectum and occlude or partiallyocclude the rectum. The expandable body can be directly or indirectlyconnected to the segments that form the proximal hinge. The body can beconnected in such a way that the hinge is still allowed to fold. Forexample, the expandable body can comprise a flexible or elastomericmaterial that is affixed to the hinges, such that the flexible orelastomeric material moves with the hinges (e.g. soft material 108 and112 partially serve to connect the extendable portion to the stabilizingbody).

In particular embodiments, the extendable portion and/or its support canencompass a portion of the stabilizing body and the collapsible frame.It can, for example encompass a portion of the stabilizing body andcollapsible frame that changes shape between the collapsed andun-collapsed state. In the example of FIGS. 1A-1E, this portion of thestabilizing body comprises a hinge 42, but it can comprise any number oftypes of joints, as described elsewhere in this disclosure. Theextendable portion and/or its support can change shape to accommodatethe changing shape of its encompassed portion of the stabilizing body.For example, FIG. 1D shows the expandable portion and its soft materialsupports accommodating a closed configuration where its encompassedjoint (at hinge 42) is at its most acute angle. In FIG. 1E, theexpandable portion and its supports are accommodating an openconfiguration where its joint is at an angle of 0°. Alternately, theextendable portion and/or its support can be decoupled from this motionby mechanisms described elsewhere in this disclosure.

The expandable body 14 (e.g. as shown in FIG. 1E) can alternately beconnected to a support feature which extends from the collapsing frameeither distally, proximally, or is biased laterally. Examples of suchsupport features are provided by FIGS. 9-12 and discussed further below.This support feature can transmit forces applied to the expandable bodyto the frame. In some embodiments, this support feature and/or theexpandable body do not limit the lateral collapse of the device to lessthan about 10%, about 30%, about 50%, or about 75% of the nominaldeployed width of the device. In some embodiments, this support featureand/or expandable body do not extend proximally beyond the widestlateral portion of the stabilizing body in the open configuration. Insome embodiments, this support feature does not extend proximally past aline drawn between the approximate midpoints of the lateral arms (in theexample of FIG. 2A, approximate midpoints of lateral arms are hinges 40and 44), and preferably does not interfere with the ability of themidpoints of the lateral arms (e.g. 40, 44) to reduce the distancebetween them by more than about 10%, about 30%, about 50%, about 75%,about 90% or about 100% (contacting each other). The above describedsupport feature can be configured to collapse or fold along with thestabilizing frame; this collapsing or folding being accomplished as aresult of the support feature being kinematically linked to thecollapsing frame, or by being compressed by surrounding materials.

An exemplary embodiment of an additional support feature is shown inFIGS. 9A and 9B. In this embodiment, the expandable body is more rigidlysupported by features of the stabilizing body. The advantage of moresupport for the expandable body is that the expandable body can be lesslikely to be pushed out of position due to resistance to expansion fromthe vaginal walls, stool pressure or other anatomical forces such as acough. The embodiment of FIGS. 9A and 9B include two additional supportsegments 902 mounted to the proximal frame segments where the expandablebody is supported. These segments can be mounted via joints such ashinges so that they can move with respect to the frame in a defined way.In this particular embodiment, these additional segments are also hingedto each other, further constraining their motion. Alternatively, thesesegments can be coupled to the frame in other ways such as via anadhesive or a flexible adhesive that more loosely constrains the motionof the additional segments. The geometry and mounting of the segmentscan be such that when collapsed, they do not interfere with thecollapsing frame. This geometry is possible by the size and shape of thesegments which allows them to fit within the space created by thecollapsed segments 36 and 38. In the embodiment of FIGS. 9A and 9B, theadditional segments 902 are rounded on their proximal end and have abend on the distal end to more efficiently and supportively occupy spaceover the expandable body but not interfere with the folding for theframe. These segments can be placed between the expandable body and theframe, or they can be placed below the frame. The curved portion of thebars also prevents cutting of the cushion material and allows spacewithin segments 902 in the collapsed state for portions of theexpandable body. The additional segments 902 can optionally haveracetrack slots 904 on them through which posts fixing them to the frameare mounted. The slots are aligned to the device length in the collapsedstate. Another embodiment can have larger arcs on the proximal anddistal portions of segments 902 that slide past one another duringcollapse. This geometry can create more support in the openconfiguration. Any number of additional segments can be used to supportthe balloon in the manners described above.

In an alternate embodiment shown in FIGS. 10A and 10B, with additionalexpandable body supports 1002, a flexible or elastomeric sheet 1004(that is approximately the same size and shape of the expandable bodywhere the expandable body meets the stabilizing body) is fixed to theposterior portion of the stabilizing frame. With respect to theexpandable body, this feature can rest on either side of the frame. Atleast 1 lengthwise strut crosses the frame, extending on one or bothsides of the frame, preferably to at least half the distance from theedge of the frame to the far edge of the expandable body. The struts canbe resilient (e.g. 0.005″ spring temper steel, or 0.02″ polycarbonate),or can be rigid like the rest of the interconnected frame. On collapse,the elastomeric sheet can wrinkle or fold to accommodate to thecollapsed device profile.

In an alternate embodiment shown in FIGS. 11A and 11B, a disc of thin,stiff polymer 76 (that is approximately the same size and shape of theexpandable body where the expandable body meets the stabilizing body) isaffixed to the collapsible frame on the posterior portion where theexpandable body is connected to the stabilizing body. The disc 1102preferably has pleats 1104 along its length in multiple locations and aradius that reaches at least about 25%-90% of the distance from theframe to the far edge of the expandable body. The disc can be stiffenough to resist flexure along the pleated lines, and due to its lengthcan create sufficient support for the expandable body. On collapse, thedisc can fold at the pleats, allowing it to narrow. In some embodimentsit may also flex out of the plane of the stabilizing frame. In aparticular embodiment, disc 1102 can have holes or slits cut out toincrease flexibility and facilitate bonding.

FIGS. 12A and B illustrate another embodiment in which a flexible member1202 such as a spring temper wireform or flexible plastic shape curvesback and forth lengthwise over the frame segments supporting theexpandable body, crossing the frame at least one time. The loops canextend at least about 25-90% of the distance from the edge of the frameto the far edge of the expandable body. The spring is joined at least ateither end, widthwise, of this section of the frame. An examplethickness of a spring wire is about 0.020-0.060″, more preferably0.025-0.040″. On collapse, flexible member 1202 squeezes togetherwidthwise and can also flex towards the device's anterior or posterior.In an alternate embodiment, flexible member 1202 has a rectangularcross-section at least 1.5-3 times as tall as it is wide. This shape canincrease the support of the extendable member but retains its ability tocollapse. In another alternate embodiment, instead of crossing theframe, flexible member 1202 can comprise one or more separatecomponents; where there are more than one, one resides mainly on theproximal side of the frame, and one resides mainly on the distal side ofthe frame, without either fully crossing the frame. In anotherembodiment, the loops of flexible member 1202 are maximally stressrelieved and take up the majority of the area under the expandable body

Whereas at least some of the examples above include supporting featuresfor the expandable body that collapse within the same plane as thestabilizing frame, these same mechanisms, as well as the expandable bodyitself and any general support structure for the expandable body, canreside above or below the plane of collapse, such that collapse is notinterfered with by the expandable body or its supports. This can beaccomplished, for example, by mounting the expandable body or itssupports to the stabilizing body via one or more flexible connections.An exemplary embodiment is shown in FIGS. 13A and 13B, where theexpandable body 14 is a balloon mounted to a flexible platform 1302. Anexemplary material for this platform is a sheet of silicone (e.g. 0.04″silicone, 40-60 A durometer), bonded directly to the stabilizing body.In the open state, as shown in FIG. 13A, the platform 1302 partiallyspans the open space of the stabilizing body 12 such that the balloon issupported. In the collapsed state, as shown in FIG. 13B, the platformconforms to the collapsed state via flexing. It can alternatelytransition from the collapsed state to the open state by stretching,instead of folding; or by a combination of stretching and folding. Inthe collapsed configuration, the expandable body and the platform canreside in the plane of the stabilizing body, or it can preferentiallyreside anterior or posterior to the stabilizing body.

While in the example described above in relation to FIGS. 2A-2E, thewidth of the segments was generally constant, in some additionalembodiments, as shown in FIG. 14, the width of the segments can varyalong their length. For example, the width 37 of the segments can widennear the hinges to allow for enhanced hinge constraint, and narrow awayfrom the hinges 39 to allow for a more slender profile or to accommodatemore padding to interface with body tissue.

The structure of the device can also be considered as a set of linkages.In the embodiment shown in FIGS. 2A and 2B, the device comprises a 4-barlinkage. The device can be considered as such as long as there are 4segments coupled by 4 movable joints. Fewer than 4 bars can also be usedto collapse the device. For example, FIGS. 15A and B illustrates analternate embodiment of a device 1500 in which there are minimally 2rigid segments 1502 connected by a hinge 1504. A spring 1506 or springsare used in this embodiment in place of rigid segments. A hinge 1504between the rigid segments 1502 can be lockable, which fixes therelative angle or curvature of the two rigid segments 1502, andtherefore fixes the rigidity of the stabilizing portion in a lateraldirection. In one embodiment, the spring 1506 is biased to be morestraight than it is in the open configuration. This bias will tend toopen the device from a collapsed state and extra force is required toreturn the device to a collapsed state (FIG. 15B). In anotherembodiment, the spring is biased to be more curved than the openedstate. This bias will tend to collapse the device (if unlocked) andextra force is required to open the device. In another embodiment, thespring encompasses more of the device perimeter, so that forces appliedlaterally to the device engage a spring, rather than the solid, locked,frame. The spring in FIGS. 15A and B can alternately be a band 1508 offlexible material, with the longer dimension of its cross-sectionalprofile extending in the direction perpendicular to the plane of thestabilizing body, as shown in FIG. 15C. This will allow in-planeflexibility similar to the spring, as shown in the collapsedconfiguration of FIG. 15D, but will limit the amount of out-of-planebending due to the profile of the band's cross-section.

Alternate embodiments comprise a frame structure with segments that areless curved than the segments described above (e.g., segments 32 and34). This results in a different collapsed form, wherein other aspectsof the invention as disclosed herein still apply alone or in combination(e.g. placement of expandable body at periphery; placement of expandablebody approximately over distal hinge; use of single locked joint;specific locking mechanisms; unlocking features; removal features; softcovering; gripping surfaces and features; and 3 or more constrainedhinges). Exemplary embodiments including straighter segments 66 areshown in FIGS. 5A and 5B, as well as 6A and 6B. FIGS. 6A and 6Badditionally illustrate an embodiment in which a pair of opposing hinges42, 46 (in this case, the proximal and distal hinges) are offset fromthe rest of the segment towards the center of the device. This allowsfor collapsing without as much overlap of the segments, as the offsetaround hinges 42, 46 create a space between sides of the device in acollapsed state, therefore providing for a collapse with lessinterference, allowing more space for internal components such as theexpandable body. Furthermore, the offset hinges provide for more spacebetween the segments; the larger the offset, the larger the space inbetween the segments when collapsed.

Additional Locking Embodiments

FIGS. 16A-16C illustrate an embodiment of a device frame 1600 thatutilizes an over-center lock. This embodiment provides for a collapsibleframe with two shorter segments 1602 on the distal portion of the framethat allow the device to be stable in a collapsed (FIG. 16A) or openconfiguration (FIG. 16C). The segments 1602 can be roughly symmetricalacross a line drawn between hinge 1606 and 1608. Once the device isinserted, pressing inwards in the direction of arrow 1609 on the twosegments, as indicated by the arrow in FIG. 16B, causes them to passthrough a wider state, until they pass a line 1605 drawn between thelateral hinges. One or both of segments 1602 have a raised feature 1604that does not inhibit the motion of the other segment 1602 in thecollapsed state, but when the segments 1602 are flipped inward, as shownin 16C, the features 1604 interact with the other segment's motion,creating a hard stop which limits the amount the frame can collapse. Atthis point, further force in the direction of arrows 1609 does not causeany of the hinges to rotate further as they are fully kinematicallyconstrained. The segments 1602 are located distally to make it easierfor a patient to reach them with a finger. A pull cord on the segments1602 when activated, can pull the short segments back distally, asindicated by the arrow of FIG. 16C, and allow the device to collapse andbe withdrawn. Force from the walls of the patient's vagina cause thedevice to remain stably open, but can be assisted by a widthwise springelement that can prevent accidental collapse if the cord is pulledinadvertently.

FIGS. 17A-C illustrate an embodiment of a device frame 1700 comprising apin-in-notch design. This embodiment provides for a collapsible framewherein a pin or tooth 1702, preferably spring loaded, can lock thedevice into a stable state. The spring can comprise a wireform 1704 withfeet 1706 offset from one another to generate force when the spring islifted out of plane. As the device is opened, notches 1708 onneighboring segments 1710 of the device frame align allowing the toothto drop in. At this point, further movement of the segments relative toone another is prevented. At least one of the segments has a ramped face1712 leading up to the notch so that when transitioning from a collapsedstate to the open state, the spring rides up the ramp, and until the pincan engage. In this embodiment, one segment 1714 of the two segments isdoubled up sandwiching its neighboring segment. Once the pin hasengaged, the pin can be lifted to allow the segments of the device torotate freely relative to one another. The notches 1708 have slightlycurved walls to prevent them from trapping the pin 1702. A lever 1716can be included to manipulate the pin and/or spring into the correctplacement and facilitate its actuation. In FIG. 17B, the lever 1716 issandwiched between the doubled up segments and allows the pin 1702 to belifted from the notch evenly via a pull cord attached to its loop, bypulling in the direction indicated by the arrow in FIG. 17B. Anadvantage of this lever is that it can fix the location of a tensileelement with respect to the pin and reduce any rotational moments (in adirection out of the plane of the stabilizing body) applied to the pinduring removal. The pull cord can pass through the lever to the frame sothat once the tooth has been lifted free of the notches, the force ofthe user removing the device transfers directly to the frame.

FIGS. 18A and B illustrate an exemplary rotating lock design. Thisembodiment provides for a collapsible frame wherein the locking featureis activated by rotation (out of the plane of the stabilizing body) of afeature. In this particular example, two segments 1800 of the frame(preferably the distal-most segments in a frame such as 32 and 34 asdescribed in FIG. 2) have rounded tips 1806 that are constrained withinthe locking mechanism 1802 like a ball-in-socket joint. The lockingmechanism houses the segments 1800 and in one orientation has slots 1804that allow the frame segments to swing inwards (direction of 1808),collapsing the device for insertion or removal. These slots can beexposed to the segments when the user rotates the locking mechanism (anexemplary rotation direction is shown by arrow 1812). When these slotsare exposed to the segments, the segments are free to rotate into them,causing the device to collapse. Once the segments enter the lockingmechanism's slots, their presence in the slots interferes with thelocking mechanism's ability to rotate in the direction opposite of arrow1812. The rotation of the lock mechanism when switching the device to acollapsible state can be against a spring element. This spring elementcauses the locking mechanism to return to a locked state when the deviceis opened sufficiently such that the segments clear the slots, allowinga return rotation of the lock mechanism. The pull tab (e.g. tab 1810) orcord can assist in device removal as well as unlocking. In FIGS. 18A and18B, only two segments of a collapsible frame are shown. These can beconnected to additional segments as described elsewhere. As shown, withball-in-socket joints at one end which are capable of allowing 3 degreesof rotational motion, there are preferably 3 other joints among thesegments comprising the full interconnected collapsing frame which areconstrained to allow one degree of rotational motion. The segments 1800can also protrude through the rounded ends 1806, in which case it ispossible for the segments to be further constrained in motion byinterference with the interior surfaces of the lock mechanism. Theball-in-socket joint serves an additional purpose of preventing anytranslative motion between the ends of segments 1800. In other words,the lock mechanism constrains and fixes the position of a portion (inthis case, the approximate terminal ends) of the segments 1800 withrespect to each other and other portions of the stabilizing body. Insome cases, in the closed state, a lateral force applied to segments1800 can create a rotational force on the lock housing. This is due tothe segments pressing against an internal surface of the lock housing.This can potentially lead to enough of a rotational force that the lockhousing rotates and the segments are allowed to move into the slots. Anembodiment for preventing this comprises a detent in the lock mechanismsuch that when the device is inserted and allowed to open, the lockmechanism rotates until frame segments 1800 are presented with a detent1816. This detent limits the rotation of the lock mechanism byinterfering against a segment 1800.

More generally, a housing can be used to house portions of adjacentsegments such that at one rotational position, the segments are fixed ina particular degree of freedom (e.g. fixed from rotating in thedirection that causes the collapse of the stabilizing body), and atanother rotational position, they are free to move in a direction thatcauses the collapse of the stabilizing body. Provisions should also beprovided to prevent the ends of the segments that interact with thehousing from translating apart from each other. While the aboveembodiment accomplishes this with ball-in-socket joints, it can beaccomplished by other means as well, including, but not limited todirect connection of the segments via a flexible joint or a hinge.

FIGS. 19A and 19B illustrates a device frame 1900 comprises four curvedarms connected by joints to form a loop. The frame 1900 comprises afirst arm 1902 1904 at one end of the arm 1902. The frame 1900 alsocomprises a second arm 1906 with a. Relative rotation between arms 1902,1906 opens the frame 1900. Rotation sufficient to reach the lockingpoint allows tab 1810 access to the notch. A tab 1810 can be configuredto engage the notch, fixing the arms 1902, 1906 in the openconfiguration, as shown in FIG. 19A. The tab 1910 can be rotatably fixedto the frame 1900, as shown in FIG. 19B.

FIGS. 20A-C illustrates a device frame 2000 comprising a rotating hingelocking mechanism. The frame comprises four curved arms connected byjoints to form a loop. This embodiment provides for a collapsible framewith a locking mechanism that consists of a hinge that when rotated outof plane prevents the frame from collapsing. One embodiment of thisdesign is a frame with 3 hinges 2002 in plane and 1 hinge 2004 that isable to rotate. Resilient members, e.g., over-wound springs 2006attached to the frame segments, keep the rotatable hinge 2004 out ofplane until the user, via a finger tab or pull cord, rotates the hinge2004 in the direction indicated by arrow 2008 in FIG. 20B, into plane.Once in plane, the frame 2000 is able to collapse, as shown in FIG. 20C.An advantage of the design is a lack of mechanical disadvantage. Thelocking mechanism rotates in place until the point at which it canrelease.

FIGS. 21A and B illustrates a device frame 2100 comprising four curvedarms connected by joints to form a loop. The device comprises aresilient or spring element 2102 (e.g., a rubber spring) extendingacross the frame 2100. The resilient element 2102 can be used to assistin device opening. The resilient element 2102 can have a resting statecorresponding to the frame 90 being in an open configuration. In someembodiments, the resilient element 2102 can have a resting statecorresponding to the frame 2100 holding the stabilizing body open to adegree greater than the degree desired when the device is inserted inthe vaginal cavity of a user. Once inserted, patient anatomy can applypressure to collapse the device to the desired position based onparticular anatomy. Upon application of force during device removal, thestabilizing body can naturally collapse as it passes through narroweranatomy. Hard or active stops can be used to constrain frame dimensions.

FIGS. 22A and 22B illustrate an embodiment of two arms 2200, 2202 of adevice frame comprising detents that can be used to lock a frame in anopen configuration. Arm 2200 includes a resilient protrusion 2204 at anend of the arm; arm 2202 includes a resilient protrusion 2206 at the endof the arm, on the surface of arm 2202 facing arm 2200. Arm 2200includes a depression 2208 configured to mate with protrusion 2204, andarm 2202 includes a depression 2210 configured to mate with protrusion2206, the depression 2210 positioned on the surface of arm 2202 facingarm 2200. Opening the frame can cause the protrustions 2204, 2206 tocatch on the depressions 2208, 2210, locking the frame to resist deviceclosure. The protrusions can comprise spring loaded balls, leaf springs,and the like. In some embodiments, the protrusions can catch on theframe edges.

FIGS. 23A-C illustrate an embodiment of a locking mechanism 2300 betweentwo arms 2302, 2304 of a device frame. A spring 2306 or other resilientelement extends between ends of the arms 2302, 2304. FIG. 23A depicts afirst open configuration, and FIG. 23C depicts a second openconfiguration. The spring 2306 is in a resting state in bothconfigurations. FIG. 23B depicts the spring 2306 being stretched as theframe transitions between open configurations.

Described above are device frames comprising four curved arms, allowingthe frame to collapse in two sections, (e.g., FIGS. 2A-2G, 19A-19B,20A-20C). In some embodiments, the frame comprises more segments, asshown in FIG. 24A. The frame 2400 is shown in a collapsed configurationin FIG. 24B. Increasing the number of segments can allow the frame tocollapse more narrowly, as each section comprises less of the totalframe curvature. The frame 2400 shown in FIGS. 24A and B comprises 6segments and collapses into three sections 2402. Such frames can requiremore locking mechanisms than a frame with 4 or less segments, or can usea combination of a single locking mechanism (e.g. a lock of theembodiments described above, at hinge 2401) and one or more rotationlimiting features to limit the direction that certain segments incertain positions are able to rotate. In an exemplary embodiment, theselimiters comprise a feature on one segment that interferes via collisionwith a feature on another rotationally-linked segment at a certainrotational position. More specifically, the embodiment shown in FIGS.24A and 24B utilizes hooks 2404 on segments that engage pins 2406 onrotationally-linked segments. These features allow the joints to rotatewith respect to each other in one direction to allow collapse, butprevent rotation in the other direction. When a single lock (e.g. athinge 2401) is engaged, the limiters 2404 and 2406 prevent the othersegments from rotating in the collapse direction, rendering the openconfiguration is stabilized.

Another embodiment shown in FIG. 24C shows a means of stabilizingmultiple segments by utilizing features such as tapered surfaces thatallow the segments to act like vertebrae 2410 that are hinged on theirwider side 2412, limiting the ability to rotate in one direction.Similar to the above example, this component's shape allows the use of asingle locking mechanism to secure the whole assembly in an openconfiguration. Also shown in FIGS. 32A and 32B is a similar embodimentwith a tensile element 3204 running through the segments that can betensioned to pull the tapered faces of segments 3202 together, aligningthe segments in the open configuration.

FIG. 25A illustrates an embodiment of a locking mechanism 2500 between afirst arm 2502 and a second arm 2504 of a device frame. The first arm2502 comprises a protrusion 2506 at an end of the arm. The second arm2504 comprises an opening 2508, (e.g., a slot, a tube, or the like). Theprotrusion 2506 is disposed within the opening 2508. Sliding the Slidingoff or rotating the opening 2508 can free the protrusion 2506 and allowthe frame to collapse. For example, the protrusion 2506 can rotate at awider location 2510 in the opening 2508. When the protrusion 2506 isslid into the wider location 2510, the arms 2502, 2504 can be free torotate, as shown in FIG. 25B.

In some embodiments, the stabilizing body can be configured to collapseby folding out of the plane of the primary structure, (e.g., foldingtogether opposing portions of the stabilizing body). FIGS. 26A and Billustrates an embodiment of a frame 2600 configured to collapse byfolding the two sides 2602, 2604 over one another. FIG. 26A illustratesthe frame 2600 in a collapsed configuration, forming a crescent shape.

FIG. 27A illustrates an embodiment of a frame 2700 configured to foldtogether to form a crescent shape, as shown in FIG. 27C. The frame 2700is then configured to straighten out as shown in FIGS. 27D and E. Asshown in FIG. 27A, the frame 2700 comprises a first pair of opposingjoints 2702, 2704 and a second pair of opposing joints 2706, 2708.Joints 2702, 2704 allow the frame 2700 to fold over on itself. Joint2702 is out of plane from joint 2704. Joint 2704 must be rotated asshown in FIG. 27B, before joints 2702 and 2704 can be used to fold thedevice over on itself, as shown in FIG. 27C. Joints 2706, 2708 allow thedevice to straighten. Joints 2706, 2708 cannot rotate when the frame2700 is in a planar configuration as joints 2706, 2708 are out of planewhen the frame 2700 is in a planar configuration. Once joints 2702, 2704are rotated sufficiently, joints 2706, 2708 are able to rotate andstraighten the device, as shown in FIGS. 27D and E.

While FIGS. 27A-27C demonstrate an out-of-plane collapsible device witha particular type of locking mechanism (rotatable hinges), devices thatfold in this fashion can be locked by any number of locking mechanisms,including the other locking mechanisms described herein.

FIGS. 28A-C illustrate an embodiment of a frame 2800 comprising acylindrical shape. As shown in FIG. 28A, the body 2800 comprisesbi-stable walls that curve inwards such that only force generated byhooking or pulling from the inside of the body 2800 can cause it tocollapse. FIG. 28B illustrates a top view of the frame 2800 with anarrow indicating the location at which force can be applied to collapsethe frame 2800. FIG. 28C illustrates a top view of the collapsed frame2800.

FIG. 29A illustrates an embodiment of a generally loop-shaped frame 2900(e.g., circular, ovular, rectangular, etc.) configured to collapse bycrossing over itself. The collapsed configuration can resemble aninfinity sign, as shown in FIG. 29B. The frame 2900 can be twistedfurther, resulting in a narrower profile, as shown in FIG. 29C. In someembodiments, the frame 200 comprises shape memory materials or metals.The frame 2900 can comprise wires, ribbons, beams. In some embodiments,the frame 2900 comprises beams with flat or concave cross-sections.

FIG. 30A illustrates an embodiment of a frame 3000 comprising, at leastin part, a shape memory alloy. The shape memory alloy can be at rest atbody temperature. The frame 3000 comprises one or more lumens 3002allowing for the application of fluid or current. Application of hot orcold fluid can cause the frame 3000 to extend and narrow (e.g., duringinsertion and removal). In some embodiments, application of a currentcauses the frame 3000 to change shape. FIG. 30B illustrates the frame3000 in a narrowed configuration.

FIG. 31A illustrates an embodiment of a frame comprising two internalcomponents 3102 each comprising a gap or flexure 3104 and a hinge 3106,as shown in FIG. 31A. The internal components are rotatable relative toone another. The frame 3100 is locked in an open configuration when theflexures 3104 are not aligned, as shown in FIG. 31B. Rotation of thecomponents 3102 can cause the flexures 3104 to align (FIG. 31C),allowing the frame 3100 to be collapsed. In some embodiments, an elasticcomponents (e.g., a spring) can keep the components 3102 in a lockedstate. In some embodiments, the frame 3100 can be locked by rotating orsqueezing.

FIGS. 32A and B illustrate an embodiment of a frame 3200 comprisingmultiple segments 3202 and a tensile member 3204 (e.g., a string)extending through the segments 3202. The segments 3202 comprise taperedfeatures like vertebrae that are hinged on the wider side. When thetensile member 3204 is not applying tension, as shown in FIG. 32A, theframe 3200 can be collapsed or manipulated. When tension is applied, asshown in FIG. 32B, the tapered faces of the segments 3202 engage, andframe 3200 is locked into an open configuration. Tension can be appliedvia an external force. The tensioning member, while facilitating theopening of the device, is not required for locking. A single lock canalso secure the entire vertebrae once it is opened.

FIG. 33A illustrates an embodiment of a frame 3300 comprising a lockingmechanism to stabilize the open configuration. The frame 3300 isgenerally loop shaped (e.g., circular, ovular, etc.). The frame 3300includes a break, creating two frame sections. FIG. 33B illustrates thebreak in the frame in more detail. A pin 3302 is positioned at the endof a first frame section. An aperture 3304 configured to receive the pinis positioned at the end of a second frame section. The pin 3302 andaperture 3304 can snap together to hold the frame 3300 in an openconfiguration. In some embodiments, the frame 3300 is in a resting statewhen in the open configuration, so the two frame sections can bedisconnected prior to collapse. Other connection mechanisms are alsopossible. For example, hook features can be used.

FIG. 34A illustrates an embodiment of a lock mechanism 3400. The lockingmechanism comprises a locking member 3402 that can rotate or slide overthe unfolded hinge 3404, preventing it from folding, as shown in FIG.34A. The locking member 3402 can comprise a sheath, bar, rod, or thelike. A string, tube, or the like can be used to move the locking member3402 away from the hinge 3404, allowing it to fold. FIG. 34B illustratesthe locking member 3402 rotated away from the hinge 3404. FIG. 34Cillustrates an embodiment of a folded frame 3406 after rotation of thelocking member 3402 away from the hinge 3404.

FIG. 35 illustrates a device frame 3500 with a locking mechanism on itsdistal portion which comprises two additional locking segments 3502,3504 that can be placed into a position that prevents the hinge nearestthe locking segments from further closing. The locking segments, whenthe device is collapsed, as shown in FIG. 35A, rotate towards oneanother (become more parallel) like the frame segments 3506 they areattached to. The rotation occurs at the lock segment central hinge 3512.The frame segments have their own central hinge that is hidden in theimage by the lock segments. In this way, the entire frame, including thelock segments, can collapse without occupying a significant portion ofthe space between the frame segments, allowing space for cushioning andcomponents of the extendable body and for the stabilizing body to have apassage through it for drainage of vaginal fluids. The lock segments aremounted on the frame segments at an arc distance, from the framesegments' central hinge, of at least 1/10 but not more than half the arcdistance to the lateral frame hinges 3508, 3510. The more distallocation places the lock segments closer to the vaginal opening andimproves the user's ability to locate and press the segments. When thedevice is collapsed, the lock segments protrude only gently from theframe, facilitating device insertion. As the frame opens, the locksegments rotate open, becomes more collinear along their hinges. At thepoint or just before the frame is in its open state, the lock segmentsbecome more collinear, as shown in FIG. 35B. The user can then press onthe lock segments with a finger to push them proximally. The raisedfeatures on the lock segments 3514 extend far enough past the frame sothat the user can fully push the lock segments in before contacting theframe itself. In other embodiments, the frame segments do not haveraised features, and the patient uses a tool to press the featuresinwards. As the lock segments are pushed by the patient, the frame willpass through a temporary wider (laterally) state, as shown in FIG. 35C,before the lock segments begin rotating the other direction (lesscollinear) and the device becomes narrower laterally, as shown in FIG.35D. In this way, further compression of the device forces the locksegments to rotate inwards even further and prevents them from returningto their collapsed state. The lock segments have hard stop features 3516which do not interfere with one another until reaching their lockedposition, at which point they contact a counter feature on the othersegment. In some embodiments, one feature is the hard stop and counter.Once the hard stop is engaged, further lateral compression (e.g. appliedat the lateral hinges 3508, 3510 of the device) is transferred in abending moment along the length of the segments (e.g. segment 3506) thatconnect to lock segments (e.g. segment 3502) to the lock segments 3502,3504 and their hard stop, preventing the device from collapsing. Inorder to allow the device to collapse, the patient can hook a fingerinside the frame and pull the lock segments forward until they passthrough their collinear configuration. At this point, lateralcompression can again collapse the device. Alternately, a pull cord orcomponent attached to the lock segment allows the user to pull thesegments forward to allow collapse. The length of the lock segments asmeasured between their hinge to the frame segment and their own centralhinge, can be ≥about ¾ and ≤to the distance between their hinge to theframe segment and central hinge of the frame segments. The lock segmentsbeing shorter reduces the lateral expansion required to pass throughtheir collinear configuration, and therefore the force required to lockthe device. In the locked configuration, the angle of the lock segmentsfrom parallel can be about 5-45 degrees; or about 10-30 degrees. Thisangle, when smaller, makes the open configuration, shown in FIG. 35D,more stable, but when larger, e.g., about 45-135 degrees, allows forsmaller lock segments and places less moment on the hard stops, makingthem more robust and easing the force required for collapse. The hardstop features are located a distance that is about >equal to thediameter of the central hinge axle and ≤the distance between the hingeson a lock segment, more preferably about ⅛ to about ½ the distancebetween the hinges on a lock segment, where a longer distance increasesstability, but where a shorter distance makes the lock segments morecompact.

This embodiment shows very similar and symmetrical lock segments, but inother embodiments, the lock segments can be asymmetrical in theirmounted location, length, or shape, and may not hinge at the center ofthe device.

Another embodiment can use lock segments that are extendable with aspring loading, assisting in their opening and closing and allowing themto be longer than the distance between their hinge mounting them to theframe segments and the frame segments' distal hinge.

The collapsing and locking mechanisms described herein can be applied innumerous combinations or permutations. It will be appreciated that theframe or other device components need not necessarily form circular orplanar bodies. Other configurations that allow for ease in collapsingand opening are possible. The embodiments disclosed herein can beincorporated with electromagnetic components, other adhering elements(e.g., Velcro, temporary adhesives, magnets, etc.).

Unless otherwise specified, the frames described herein can be lockedinto an open configuration by applying force to anterior distal portionof the frame. Force can be applied using an external device (e.g., anapplicator) or by user hands. The frames described herein can beunlocked by pulling on anterior distal portion of the frame. Pulling canbe performed using an external device (e.g., a hook, an applicator), bya triggering mechanism (e.g., a string, tube, cord, wire, and the like),or by user hands.

While some of the embodiments described herein focus on applications forfecal incontinence, the devices and methods disclosed herein are notlimited to devices for controlling fecal incontinence and can be appliedto various types of vaginal devices. For example, the structuresdescribed herein can also apply to devices inserted into other bodycavities such as the rectum.

An additional advantage of the location and configuration of theexpandable body is that it can be used to help open the frame. In anexemplary embodiment, shown in FIG. 36A, the expandable body 3600resides at least partially within the perimeter of the collapsible frameand is attached to at least two segments 3602 of the frame. Thesesegments can be arranged and configured to allow the expandable body toreside between them when the frame is collapsed. When inflated (shown inFIG. 36B), the expandable body 3600 expands and drives open the segments3602. This can be done until a locking mechanism is engaged once theexpansion crosses a pre-defined threshold (as described on otherembodiments). In some examples, the expandable body is a bladder of ahigh durometer. The attachment between the segments and the balloon canoccur as far from the joint 3604 that joins these segments as possible,maximizing potential leverage. Exemplary distances are about ¼ to ½ ofthe distance from the joint to the lateral hinges 3606 and 3608. Theattachment between the expandable body and the frame segments 3602 cancomprise a section of material that is more resilient than the bladder,providing features to transmit force to the frame segment that has agreater area for fluid pressure to act over. More generally, otherembodiments are possible wherein the expandable body can expanded bymeans other than inflation, such as a linkage that is operably connectedto the frame such that when the expandable body extends, the frameopens. Optionally, the bladder can hold the frame open without the useof a locking mechanism. In this case, deflation of the bladder can beused to allow the frame to collapse, or just become less resistant tolateral collapse.

In some embodiments of devices using the expandable body to driveopening, the frame is configured to increase the advantage of inflationby shortening the frame segments near the expandable body. FIGS. 37A-Dshow expansion of a frame member comprising two sides X1 and two sidesX2. As shown in FIGS. 37A and B, when X1=X2, expansion of the expandablebody 3702 in the center of the frame causes the sides to expand equally,creating an angle α of about 45° between X2 and horizontal. As shown inFIGS. 37C and D, when X1 is greater than X2, expansion of the expandablebody in the center of the frame causes the sides to expand unevenly,resulting in an angle α of less than 45°. A lower angle α indicatesincreased advantage in the driving open of the frame.

FIGS. 38A and B illustrate an embodiment of a frame 3800 configured tobe driven open by expandable member 3802. FIG. 38A illustrates a topview of the frame 3800. The expandable member 3802 is positioned at onehinge point 3804 of the frame and is connected by a tensile element(e.g., via string 3806) to an opposing hinge point 3808. The string 3806can be connected at a location 3810 on the expandable member thatextends away from the frame 3800, as shown in the side view of FIG. 38B.As shown in FIGS. 38C and D, expansion of the expandable member 3802moves the location 3810 away from the frame 3800, causing the string3806 to pull on hinge point 3808, drawing hinge point 3808 towards hingepoint 3804. The movement of hinge point 3808 towards hinge point 3804causes the frame 3800 to open, as shown in the top view of FIG. 38E.FIG. 38F illustrates a side view of the frame 3800 and expandable member3802.

In an embodiment shown if FIGS. 2A-2H, there are two rigid portions(e.g. segments 32 and 34), joined at a lock-able joint (e.g. hinge 46)that allows and disallows the portions 32 and 34 to move with respect toeach other. In particular, the lock-able joint 46 allows and disallowsthe portions 32 and 34 to move such that the angle between them changes.These portions can be joined to each other at the periphery of thestructural perimeter. Together, these portions span the width of theopen device, with one portion spanning predominantly one lateral side ofthe open device, and another portion spanning predominantly anotherlateral side of the open device. Preferably, these portions comprise aportion of the structural perimeter. More preferably, they comprise atleast 25% of the structural perimeter. Preferably, these portions arejoined at the distal or proximal end of the device (in-situ). Connectedto the non-locked end of these two portions 32 and 34 (the ends that arenearest the widest point of an open device as shown in FIG. 2A) can beadditional rigid portions 36 and 38. Alternatively, a spring-likeportion, or a combination of one or more spring like portions and onemore rigid portions can be connected to the non-locked ends of 32 and34. These additional portions can themselves by joined, forming a loop,or additional portions can be added in between them. As describedelsewhere, there can be a non-rigid segment of a similar or dissimilarmaterial between the additional portions as well. A single “portion” asdescribed above referring to the two rigid portions joined at theperiphery of the structural perimeter can contain multiple distinctparts, so long as they provide rigidity at least in a manner thatresists collapse when the locking mechanism is engaged.

Improved Insertion and/or Removal

In some embodiments, the intra-vaginal device is deformable to allow formanipulation of the device during insertion and removal. In suchembodiments, it can be difficult for a user to hold a device in thedeformed position during the entire insertion and/or removal.Intra-vaginal devices including retaining features to retain thestabilizing body in a collapsed or folded configuration can aid theinsertion and removal process.

FIG. 39A illustrates an embodiment of a device 3900 comprising a latch3902 that catches when the device is folded together, for example,during insertion or removal. FIG. 39B illustrates the latch 3902 in moredetail, with the latch components 3904 separated. Squeezing the devicefurther can cause the latch to release, allowing it to open, as shown inFIG. 39C.

FIG. 40A illustrates an embodiment of a device 4000 with mating features4002 on opposing sides of the device 4000. The mating features 4002(e.g., press fit features snap fit feature, suction, magnets) areconfigured to engage one another by being pressed together. The engagedmating features 4002 can keep the device in a collapsed configurationduring insertion and/or removal, as shown in FIG. 40B. When separationforces that can overcome the engagement of the features 4002 areapplied, the device can open.

FIG. 41A illustrates an embodiment of a device 4100 comprising a tensilemember 4102 extending between opposing sides of the device. The tensilemember 4102 can cause the frame to fold or collapse by pulling the sidestogether upon application of tension to the tensile member 4102. Afriction mechanism 4104, such as slip knot shown in FIG. 41B can be usedto cause friction on the tensile member 4102 to maintain the device 4100in a collapsed configuration. FIG. 41C illustrates an embodiment using aclamp 4106 as the friction member. The clamp 4106 can be released bypulling on the tensile member 4102. The tensile member 4102 can beconfigured to extend from the vagina for ease of use. In someembodiments, the tensile member 4102 is used to pull the device 4100 ouror tilt the device 4100 to a position which is easier for a user toreach.

FIG. 42 illustrates an embodiment of a frame 4200 comprising a keystonefeature 4202. The keystone feature 4202 covers a hinge or flexure 4204in the frame 4200. The keystone feature 4202 can be removed to exposethe hinge or flexure 4204. In some embodiments, a pull wire or cord canbe used to remove the keystone feature 4202. After removal of thekeystone feature 4202, the frame 4200 is able to collapse.

FIGS. 43A-C illustrates an embodiment of a device 4300 that is filled,at least in part, by a foam (e.g., slow recovery foam). The device 4300can be compressed for insertion, as shown in FIG. 43A. Followinginsertion, the device 4300 can either expand passively or be inflatedwith air or fluid, as shown in FIG. 43B. FIG. 43C illustrates aninflated device 4300. Deflation of the device 4300 can aid in deviceremoval.

In some embodiments, the device comprises, at least in part a flexiblecasing full of smaller pieces of hard material. The device can flexuntil vacuumed, which can cause it to become rigid. The addition of airor fluid can be used to soften the device for insertion and/or removal.

FIG. 44A illustrates an embodiment of a device 4400 in which theexpandable body 4402 is movable or removable in order to narrow thedevice profile for insertion and/or removal. Removal of the expandablebody can also allow the device 4400 to fold more easily. The expandablebody 4402 can be temporarily removed. Reattachment can be performedusing a pull cord 4404 as shown in FIG. 44B. Other reattachmentmechanisms are also possible. For example, an elastic component (e.g., aspring) can also be used.

In some embodiments, deflation of the device actively opens a reservoirof a lubricating material to aid in device removal. In some embodiments,one or more channels through the device allow addition of a lubricatingmaterial through an external pathway.

In some embodiments, the device includes tensile elements in line withinflation tubing. Keeping tensile elements together with inflationtubing can allow a user to more easily pull the device out. The tensileelement can be coupled to the inflation tubing. To do this, some portionof the tube is joined to the locking mechanism. This can be accomplishedby a number of features, including a cord. In some embodiments, thetensile element is inside the inflation tubing. The tubing can have anintegrated material (e.g., wire, suture) in its walls to allow thetubing to act as the tensile element. In some embodiments, the tensileelement is separate from the inflation tubing (FIG. 64). As describedabove, in some embodiments, the tensile element 6401 can act as atriggering mechanism, activating collapse or folding of the device. Insome embodiments, the tensile element simply allows the device to bepulled on. The tubing distal to the attachment to the locking mechanism,can be reinforced 6401 to prevent elongation when tensioned. The tubingcan also have one or more features 6402, 6403 to facilitate the grip ofa user. For example a bump along the tube or bead can facilitate grip.It is also advantageous to provide some portion of the tubing, distal toa reinforced section, which allows for elongation 6404. For example, incertain such embodiments, the device comprises an elastomeric portion(e.g., proximate to the inflation valve 6405). In this way, if a moredistal portion of the tubing is pulled accidentally (e.g. caught inclothing or during manipulation to add/remove fluid) there is sufficientgive in the tubing such that the device isn't unlocked. Thisconfiguration can allow for an amount of elongation before a sufficientamount of tensile force is generated to trigger the locking mechanismthat is in the range of about 0.1 cm-20 cm; in the range of about 0.5-15cm; in the range of about 0.5-10 cm. In some embodiments, the reinforcedsection of tubing extends just slightly past the introitus, at whichpoint there is a feature for grasping; distal to this, the tubing canstretch when tensioned.

The tubing can be reinforced by several means, including braiding,linear components with suitable tensile properties (e.g. string, wire),polymeric coverings. As shown in FIG. 45, in some embodiments, a cord4502, interior to the inflation tube 4504, is used to reinforce thetubing. It can be advantageous to configure this system such that thecord does not pierce the inflation tubing. This can be accomplished byconnecting the reinforcement cord first to another component, such as acylindrical fitting 4506, both ends of which are sealed to the inflationtube. Then, a separate cord 4508 can be attached to the exterior of thisfitting and connected to the locking mechanism. This same configurationcan be used on the distal end to couple the reinforcement cord to agrasping mechanism or other feature.

Referring to the examples of FIGS. 46A-46E: Instead of, or incombination with, a removal feature extending outside of the vagina, thefeature that causes the locking mechanism to disengage can be located onthe inside of the vagina; it can be further located inside the loopformed by the stabilizing body (e.g. requiring a user to hook a fingerunder the loop, as in the exemplary removal of a diaphragm) to triggerthe release of the locking mechanism. The removal feature can be anynumber of features including, but not limited to: a tab, button, tube,string, or loop. These features can also be used to facilitate removalwithout them being directly coupled to a lock-release mechanism.Specific examples of features to assist with removal are provided inFIGS. 46A-E. FIG. 46A illustrates a pull loop 4602 for finger to hook.FIG. 46B illlustrates a pull cord 4604 that passes through the inflationtubing 4608. FIG. 46C illustrates an embodiment of a pull cord 4604 runsparallel to the inflation tubing 4608. FIG. 46D illustrates a pull loop4610 that is inside the frame. FIG. 46E illustrates a pull tab 4612 thatis inside the frame. FIG. 46F illustrates a protrusion 4614 connected tolatch 48 and positioned within the device frame. All of these featurescan be used to aid in removal and/or be coupled to a locking mechanismto enable or disable the lock. Any of the features described above canbe stiff or soft and can be designed to spring-back into position afteractuation.

There can be an advantage to having only one element passing fromoutside of the vagina to inside the vagina, for both sanitary andcomfort reasons. There also can be an advantage to having a smooth (e.g.round) cross sectional profile of the element that passes from outsideto inside, and to having that element be as small as possible as to beminimally obtrusive. The above concepts of reinforced tubing meet theseobjectives.

Dampening Device Opening

As described above, intra-vaginal devices, after being inserted in adeformed position, can cause discomfort by opening too quickly. It canbe difficult for a user to control the opening of the device. Dampeningthe opening of the device can increase comfort and ease of use for theuser.

In some embodiments, portions of the device can comprise soft or stickymaterials which have less of a natural tendency to spring back to theiroriginal shape. Adjusting the durometer of at least portions of thedevice in this manner can allow for control of device opening. Forexample, as shown in FIG. 47, a top surface 4702 of the device cancomprise a soft material, for example, silicone. Upon folding the devicealong axis 4704, the opposing silicone surfaces 4702 are in contact withone another. This contact causes the silicone surfaces to adhere to oneanother, providing temporary resistance to device opening upon releaseof the device. In some embodiments, the stabilizing body comprises afirst portion comprising a first material and a second portioncomprising a second material, the first and second materials selected toresist separation upon release of the stabilizing body. The first andsecond material can be the same, as in the example above where bothcomprise silicone. In other embodiments, the first and second materialcan be different. In some embodiments, the adherence of the surface ismechanical, one example being sheets of hook and loop fabric.

In some embodiments, at least two portions of the device (e.g., opposingsurfaces) can comprises adherence features configured to temporarilycause the portions of the device to adhere to one another. For example,as shown in FIG. 48A, opposing surfaces of the device can includemicro-suction features 4800. Upon folding of the device, themicro-suction features 4800 adhere to one another, as shown in FIG. 48B.The adherence of the micro-suction features 4800 provide temporaryresistance to device opening, slowing down the opening of the device, asshown in FIG. 48C. Other adherence features are also possible. Forexample, a hook and loop feature can be used.

FIG. 49 illustrates a mechanism for dampening opening of a device frame.Two portions 4902, 4904 are rotated about the center of the device whenit is folded. FIGS. 49A-C illustrate a cross section of the frame,showing portions 4902, 4904. The joint (e.g. elastomeric connection orhinge) between the portions 4902, 4904 is encapsulated by a highlyviscous material 4908 (e.g., silicone gel), as shown in FIG. 49D. Theviscous material can slow the return of the frame to the unfolded form.FIG. 49E illustrates the path of movement of location 4906 on portion4904.

FIG. 50 illustrates an embodiment of a hydraulic dampening mechanism5002. The device 5000 includes a dual chamber mechanism configure totransfer fluid between reservoirs during folding and unfolding of thedevice. FIG. 50A illustrates the device 5000 being folded. FIG. 50Bdepicts the hydraulic dampening mechanism 5002 in more detail. As thedevice is folded, the fluid flows from the chamber 5004 past arestriction 5006, slowing the fluid movement. After release of thedevice 5000 from a folded position, the spring force in the device canpull a vacuum in empty chamber 5004 on the device frame, drawing fluidinto it. The release of the device 5000 can be controlled by the rate offluid flowing into chamber 5004.

Dampening of a device opening can be useful in devices other thanintra-vaginal devices. For example, dampening can be used in devicesconfigured for insertion into other body cavities which are configuredto expand upon insertion.

Insertion and/or Removal Tools

As described above, it can be difficult for a user to deform a deviceinto a collapsed position for insertion and/or removal. Additionally, auser can prefer to insert a device while avoiding direct contact withher hands, as manual insertion can be difficult for users withconditions such as arthritis and can cause bodily fluids or lubricationto get on the hands. This is especially true for a device that, whencollapsed, exerts outward forces which need to be continuously resistedin order to maintain a folded shape. Furthermore, devices with smoothexterior and curved surfaces can provide additional difficulty.Insertion and removal tools can be used to address these issues and helpproperly position the device in the vaginal anatomy can

In some embodiments, the device can be packed into an applicator tubefor insertion. During removal, the device can be pulled back into thesame or a different tube. In some embodiments, the tube can belubricated or constructed from low-friction materials to allow formovement of the device. In some embodiments, the tube comprises tapersand geometry appropriate for retrieving the intra-vaginal device. Insome embodiments, the intra-vaginal device comprises a string or othertensile element that can be used to pull the device back into theapplicator. In some embodiments, the applicator comprises a hook thatcan be used for retrieving the device. FIG. 51 illustrates an embodimentof an applicator 5100 comprising a hook feature 5102 and anintra-vaginal device 5104 comprising a cord 5106 or other tensileelement extending across the device frame. The hook feature 5102 can behooked onto the device 5104 and then pulled toward the applicator 5100.Pulling on the cord 5106 can cause the device to collapse. FIG. 51Billustrates an embodiment of the collapsed device 5104 being pulled intothe applicator tube 5100.

FIGS. 52A and B illustrate an embodiment of an applicator 5200. Theapplicator 5200 comprises a rotating linkage 5202 connected to atranslating component 5204. In the position shown in FIG. 52A, thelinkage 5202 maintains hold of the device 5206. Upon moving thetranslating component 5204 to the right, as shown in FIG. 52B, thelinkage rotates in a counter-clockwise position and releases hold of thedevice 5206.

FIGS. 53A and B illustrate an embodiment of an insertion and removaltool 5300 comprising arms 5302. The arms 5302 are biased in a positionseparate from one another, as shown in FIG. 53A. When the arms 5302 arein this separate position, they hold the device frame 5306 in an openconfiguration. Upon translation of a sheath 5304 over the arms 5302,however, the arms 5302 move closer to one another, collapsing the deviceframe 5306. Such a tool 5300 can be inserted into the vagina with thesheath 5304 holding the arms 5302 in a close position. Once the deviceframe 5306 is positioned, the sheath 5304 can be retracted to open thedevice frame 5306. In some embodiments, the tool 5300 comprises morethan two arms. For example, a third arm can be used to pull back on thecenter of the device.

In some embodiments, plunger type applicators can be used. In aplunger-type applicator, the device is held in a compartment of anapplicator and another portion of the applicator is actuated to push thedevice out. FIGS. 54A-B illustrate a plunger-type applicator 5400. Theapplicator comprises an applicator tube 5402 and a pusher 5404 forpushing the device 5406 out of the applicator tube 5402. The device 5406shown in FIGS. 54A and B folds down into a curved shape. The applicatortube 5402 includes a slot 5408 to accommodate the end of the curveddevice 5406. FIG. 54B depicts the device 5406 being pushed out of theapplicator 5400. FIG. 54C illustrates an applicator 5400 similar to theapplicator of FIGS. 54A and B, but comprising a different shape. FIGS.55A and B illustrate another plunger type applicator 5500 configured toaccommodate a device that is curved when folded. The applicator 5500comprises a curved shape.

In some embodiments, the applicator opening can include projectionsconfigured to control the device ejection. The projections can includesoft teeth or O-rings. FIGS. 56A-C illustrate a device being ejectedfrom an applicator 5600 comprising a sheet of material 5602 (e.g.,elastomer) comprising a slit 5604 over the opening of the applicator5600. Such projections over the opening can resist the device ejection,slowing the release of the device.

In some embodiments, external components can be used with or withouttools to aid in insertion and/or removal of the intra-vaginal device.FIGS. 57A-C illustrate an embodiment of a sheath 5700 that can be usedto hold the device 5702 together for insertion. The sheath 5700 can beconfigured to be tearable or releasable. A string 5704, shown in FIG.57A, can be configured to tear the sheath 5700. FIG. 57B illustrates thestring 5704 tearing the sheath 5700, causing the device 5702 to begin toopen. FIG. 57C illustrates the sheath 5700 fully torn, causing thedevice 5702 to be fully open. In some embodiments, the sheath can beheld together by rapidly dissolvable materials for insertion. Exposureto liquids such as lubrication, water, or vaginal fluids can cause thesheath to soften or break.

FIG. 58A illustrates an embodiment of a cap feature 5800 that can beused to hold a folded device 5802. The cap 5800 can be used to keep thedevice 5802 in a folded configuration and can also keep the hands of theuser clean. The cap 5800 can be rigid and be removed by pulling. In someembodiments, the cap 5800 can have a rigid ring 5804 with a soft center5806, as shown in FIG. 58B. The soft center 5806 can be used to ejectthe device. In some embodiments the cap can use a plunger or otherinternal mechanism to eject the device.

FIGS. 59A-C illustrate a tool 5900 that can be used to control thedevice for positioning at or within the vagina. The tool comprises ashaft 5908 and a retaining portion 5904. The tool 5900 can have an openretaining portion 5904 for holding the folded device, as shown in FIG.59A. Alternatively, the tool 5900 can have a closed retaining portion5904 for holding the device, as shown in FIG. 59B. FIG. 59C illustratesa tool 5900 with a closed retaining portion 5904 and a soft center 5906allowing for device ejection. FIG. 59D illustrates a device 5902positioned within the retaining portion 5904. FIG. 59E illustrates thedevice 5902 being ejected from the tool 5900 using a finger.

FIGS. 60A and B illustrate a snare tool 6000. The snare tool 6000comprises a loop 6002 extending from a channel or opening on the tool6000. The snare tool 6000 can be used to position the loop 6002 aroundthe device 6004 to hold it in a folded configuration, as shown in FIG.60A. FIG. 60B illustrates the loop 6002 being loosened, allowing thedevice 6004 to open. FIG. 60C illustrates a snare tool with aribbon-like loop 6006 with a cross-section having a major axis twice aslarge as the minor. The flatter material increasing grip withoutsignificantly increasing the tool profile, and can allow for bettercontrol of the device.

FIG. 61A illustrates a mechanism 6100 for holding a folded device usinga resilient shape. The design 6100 includes a bent portion on which thestabilizing body is supported, and a clasp 6102 shaped so that it canretain the stabilizing body during insertion. Once inserted, the handlecan be rotated relative to the device, allowing the clasp 6102 torelease the stabilizing body. FIG. 61B illustrates an embodiment of adevice 6104 being held in a folded configuration by the mechanism 6100.

FIG. 62A illustrates a sheet of flexible material 6200 (e.g., polymericor elastomeric) comprising openings 6202 for receiving user fingers. Thesheet 6200 can be wrapped around the device 6204 as shown in FIGS. 62Band C. The sheet 6200 can help to improve grip and cleanliness duringinsertion and/or removal.

FIGS. 63A and B illustrate a mechanism 6300 than can be used to hold adevice 6302 in a folded configuration. The mechanism comprises press-fitfeatures 6304 on a cord 6306 or strap. When the cord 6306 or strap ispulled, the press-fit features 6304 release, as shown in FIG. 63B,allowing the device 6302 to open. In another embodiment, the cord can beadjusted in length between the press fit features to accommodatedifferent device sizes.

The applicators and external components described herein can be used incombination with other embodiments described herein. For example, theapplicators can be configured to facilitate locking of frames includinglocking mechanisms by including a pusher feature configured to push onthe device base during insertion. Such a feature could be located at thetip of the tool or along the length of the tool.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthis detailed description. The invention is capable of myriadmodifications in various obvious aspects, all without departing from thespirit and scope of the present invention. Accordingly, the drawings anddescriptions are to be regarded as illustrative in nature and notrestrictive.

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached” or “coupled” toanother feature or element, it can be directly connected, attached orcoupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being “directly connected”, “directly attached” or“directly coupled” to another feature or element, there are nointervening features or elements present. Although described or shownwith respect to one embodiment, the features and elements so describedor shown can apply to other embodiments. It will also be appreciated bythose of skill in the art that references to a structure or feature thatis disposed “adjacent” another feature may have portions that overlap orunderlie the adjacent feature.

Terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention.For example, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, steps, operations, elements, components, and/orgroups thereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items and may beabbreviated as “/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

Although the terms “first” and “second” (or primary and secondary) maybe used herein to describe various features/elements, thesefeatures/elements should not be limited by these terms, unless thecontext indicates otherwise. These terms may be used to distinguish onefeature/element from another feature/element. Thus, a firstfeature/element discussed below could be termed a secondfeature/element, and similarly, a second feature/element discussed belowcould be termed a first feature/element without departing from theteachings of the present invention.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical rangerecited herein is intended to include all sub-ranges subsumed therein.

Although various illustrative embodiments are described above, any of anumber of changes may be made to various embodiments without departingfrom the scope of the invention as described by the claims. For example,the order in which various described method steps are performed mayoften be changed in alternative embodiments, and in other alternativeembodiments one or more method steps may be skipped altogether. Optionalfeatures of various device and system embodiments may be included insome embodiments and not in others. Therefore, the foregoing descriptionis provided primarily for exemplary purposes and should not beinterpreted to limit the scope of the invention as it is set forth inthe claims.

The examples and illustrations included herein show, by way ofillustration and not of limitation, specific embodiments in which thesubject matter may be practiced. As mentioned, other embodiments may beutilized and derived there from, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. Such embodiments of the inventive subject matter maybe referred to herein individually or collectively by the term“invention” merely for convenience and without intending to voluntarilylimit the scope of this application to any single invention or inventiveconcept, if more than one is, in fact, disclosed. Thus, althoughspecific embodiments have been illustrated and described herein, anyarrangement calculated to achieve the same purpose may be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of various embodiments.Combinations of the above embodiments, and other embodiments notspecifically described herein, will be apparent to those of skill in theart upon reviewing the above description.

1. An intravaginal device for the control of stool passage, the devicecomprising: a collapsible stabilizing body including a plurality ofsegments interconnected by joints and configured to modulate between anopen state and a collapsed state by movement of the segments about thejoints, an occluding portion positioned above the stabilizing body, theoccluding portion configured to provide a non-extended state and anextended state the occluding portion configured to push against arecto-vaginal septum of a user in an the extended state; and a lockingmechanism configured to maintain the collapsible stabilizing body in theopen state upon engagement of the locking mechanism and permit thecollapsible stabilizing body to collapse upon disengagement of thelocking mechanism.
 2. The device of claim 0, wherein the interconnectedsegments, in the open state, form a loop with a generally oval shape. 3.The device of claim 0, wherein the interconnected segments, in thecollapsed state, form a loop with multiple generally oval shapes.
 4. Thedevice of claim 0, wherein in the collapsed state the segments have alengthwise mid-point that is approximately half-way between a distaljoint and proximal joint, wherein a width at this midpoint in thecollapsed state is narrower than a width of a space spanned by thesegments both proximal and distal to the midpoint.
 5. The device ofclaim 0, wherein in the collapsed state, the approximate lengthwisemidpoint forms a local minimum in the profile of the device.
 6. Thedevice of claim 0, wherein the occluding portion is configured toprotrude into the rectum by pushing against a recto-vaginal septum of auser in the extended state.
 7. The device of claim 0, wherein: in theopen state, the device has a first width, a first length, and a firstheight; and in the collapsed state, the device has a second width, asecond length, and a second height, the second width being 50% less thanthe first width, the second length being greater than the first length,and the second height being substantially the same as the first height.8. The device of claim 0, wherein the stabilizing body is comprised ofmultiple interconnected segments that are joined together to form aloop.
 9. The device of claim 0, wherein the stabilizing body comprisesmultiple interconnected segments that are joined by joints, wherein atleast one of the joints comprises an elastomeric material.
 10. Thedevice of claim 0, wherein at least a portion of at least some of theplurality of segments have an arcuate shape.
 11. The device of claim 0,wherein the plurality of segments is arranged symmetrically about anaxis that extends between the locking mechanism and the occludingportion.
 12. The device of claim 0, wherein the occluding portion ispositioned above a joint between interconnected segments.
 13. The deviceof claim 0, wherein the occluding portion is positioned above a jointlocated opposite to the locking mechanism.
 14. The device of claim 0,wherein the occluding portion is an inflatable balloon, extending fromthe joint in a generally perpendicular direction from a plane of theinterconnected segments, wherein the joint is located between theballoon and a soft cushion material.
 15. The device of claim 0, wherein,in the open state, a portion of the collapsible stabilizing body has anarcuate shape and a portion of the collapsible stabilizing body has alinear shape.
 16. The device of claim 0, wherein, in the open state, theoccluding portion is positioned above the linearly shaped portion of thecollapsible stabilizing body.
 17. The device of claim 0, wherein theoccluding portion is attached to the periphery.
 18. The device of claim0, wherein the collapsible stabilizing body is configured to provide aninterconnected frame solely forming a structural perimeter of thedevice.
 19. The device of claim 0, wherein the interconnected frame iscomprised of metal segments, joined together and surrounded by a softcushioning material.
 20. The device of claim 0, wherein at least 3 ofthe interconnected joints are configured to be constrained to one degreeof freedom of angular motion. 21-111. (canceled)